Dharmendra Mondal1,
Raman Ranjan2, Alok Ranjan3, Subhash Chandra4,
Ganesh Prasad Gupta5.
1Ayurvedic
Medical Officer, Government of Bihar.
2Assistant Professor,
Dravyaguna Department, Government Ayurvedic College, Patna.
3 Assistant Professor,
Dravyaguna Department, Government Ayurvedic College, Patna.
4Director, L.N.J.P,
Bone & Joint Superspeciality Hospital, Rajbanshi Nagar, Patna, Bihar
5 Associate Professor,
Dravyaguna Department, Government Ayurvedic College, Patna.
ABSTRACT-Sandhivata is a
dhatu kshyajanya vata vyadhi. It is an age-related disorder. Based on symptoms,
it can be correlated with osteoarthritis. It is a multifactorial,
non-inflammatory degenerative disorder. Vata is the main factor responsible for
producing Sandhivata, and its description is widely narrated in almost all the
classical texts. In the present study named as A pharmaco-therapeutic study of
Ashwagandha [withania somnifera (Linn.) Dunel] and Amrita [Tinospora
cardifolia(wild.) miers] on sandhivaat w.s.r to Osteo-Arthritis, an attempt has
been made in the management of sandhivaat. This present study aim to find a
method of treatment to symptomatic relief without any side effect. Ashwagandha
and Amrita are Tikta Dravya having vatahar, aganidipaniya, and Rasayana
properties that redeem the vitalized vata and degenerative changes in
Sandhivata. The present study is taken upto evaluate the effect of Ashwagandha
churna (Group-A), Amrita satva (Group-B) and combine effect of both Ashwagandha
and Amrita satva (Group-C) and compaire the effect of all three groups. The
Ashwagandha of Group-A is more efficient than that of Group-B. (Amrita).
However, Group-C (Ashwagandha + Amrita) was shown to be more effective in
treating the patients than either Group-A or Group-B. The trial drug has given
promising results by showing improvement in the signs and symptoms of
Sandhivata.
सारांश- (संधिवात एक 'धातु क्षयजन्य वात व्याधि' है। यह उम्र से संबंधित एक विकार है। इसके लक्षणों के आधार पर इसकी तुलना
ऑस्टियोआर्थराइटिस से की जा सकती है। यह एक बहु-कारकीय, गैर-सूजन-संबंधी, अपक्षयी विकार (multi-factorial, non-inflammatory degenerative disorder) है। वात संधिवात उत्पन्न करने का मुख्य कारक है, और इसका वर्णन लगभग सभी शास्त्रीय ग्रंथों में व्यापक रूप से किया गया है।'A
pharmaco-therapeutic study of Ashwagandha [withania somnifera(Linn.) Dunel] and
Amrita [Tinospora cardifolia(wild.) miers] on sandhivaat w.s.r to
Osteo-Arthritis' नामक इस अध्ययन में, संधिवात के प्रबंधन के लिए एक प्रयास किया गया है। इस अध्ययन का उद्देश्य
बिना किसी दुष्प्रभाव के लक्षणों से राहत के लिए उपचार का एक तरीका खोजना है।
अश्वगंधा और अमृता 'तिक्त द्रव्य' हैं, जिनमें वातहर, अग्निदीपनीय और रसायन गुण होते हैं, जो संधिवात में वात और अपक्षयी परिवर्तनों को ठीक करते हैं।यह अध्ययन
अश्वगंधा चूर्ण (समूह-ए), अमृता सत्व (समूह-बी) और अश्वगंधा और अमृता सत्व (समूह-सी) के संयुक्त
प्रभाव का मूल्यांकन और तीनों समूहों के प्रभाव की तुलना करने के लिए किया गया है।
समूह-ए (अश्वगंधा) का प्रभाव समूह-बी (अमृता) से अधिक प्रभावशाली है। हालांकि, समूह-सी (अश्वगंधा + अमृता) को समूह-ए या समूह-बी की तुलना में रोगियों के
इलाज में अधिक प्रभावी दिखाया गया है। परीक्षण दवा ने संधिवात के लक्षणों और
संकेतों में सुधार दिखाकर आशाजनक परिणाम दिए हैं।)
INTRODUCTIONIntroduction- Health is the supreme foundation for
the achievement of a happy life. Humans must comprehend the ideal concept of
health and dhatu samya in order to accomplish their primary goal in life, which
is to achieve ‘Hitayu’ and ‘Sukhayu’.Due to the modernization and resulting
sedentary lifestyle, younger and older people are complaining of different
"Vatika disorders". In Ayurveda, the decade wise ageing process is
described. There are two categories of ageing, kalaja and akalaja. All khatu
undergoes Kshaya in vridhavastha, which results in vata prakopa and makes the
person susceptible to a wide range of diseases. Sandhivata
stands at the top of the list, and it is described under Vata vyadhi in all the
Samhita and Sangraha Grantha. Among the three doshas, Vata is responsible for
all chestha. Acharya Charak was the first person who described the disease
separately named "Sandhigata anila", but it is not included under the
80 types of nanatmaja vyadhi . Acharya Vagabhatta has also considered Vata
vyadhi as a maharoga. Sandhivata is a Vata Vyadhi, occurring when the patient
attains the Vatika phase of life, i.e. after 50 years of age. As in this
period, Vata Dosha is predominant, mainly occurring due to Prakopa of Vata.
This Vata Prakopa can occur for either of three reasons.• Dhatukshyajanya
Vata Prakopa• Swanidana
Sevanajanya Vata Prakopa• Avaranjanya
Vata Prakopa. Osteoarthritis is one of the most common arthritic conditions increasing
in the elderly population. It is a slow-progressing degenerative joint disease.
Many studies reported that these degenerative changes in joints arise from the
age of 30 years by the age of 70 years, 80% of the people may have radiographic
evidence of Osteoarthritis although only 25% may have symptoms. The symptoms,
such as pain and inflammation, appear in middle age. The association with ageing
is strong: the prevalence of OA increases exponentially beyond the age of 50,
and about 80% to 90% of individuals have evidence of the disease by age 65.
Osteoarthritis is a major cause of morbidity and disability, limiting activity
and impairing quality of life, especially among the elderly. The primary
complaints of patients with osteoarthritis are pain and difficulty in movement
of joints.By
considering all the described facts, it can be concluded that the complete cure
of the disease still has the status of a miracle. So, we have here made an
effort to find a safe and complete solution for the disease with the help of
Ayurvedic medicine, which is described in the context of Sandhivata chikitsa. According to
Bhawapraksh, Ashwagandha minimizes the Vata (anila) Dosha, shoth, and kshaya
due to its ushna virya, Balya, and Rasayan property. Its Doshakarm is Kapha-Vata
shamak. Ashwagandha has pharmacological action like Anti inflammatory activity,
Immunomodulation and Hematopoiesis, Adaptogenic Action, Antiparkinsonian properties,
Anti-Malignant Activity, Anti-Aging, Hypolipidemic effect. According to Acharya
charak, Amrita have Vatahar property and its Doshakarm is Tridosh shamak. Amrita has pharmacological action like
Anti-osteoporotic effects, Immunomodulatory activity, Antidiabetic activity,
Hypolipidemic effect, Antistress activity, Hepatic disorder, Wound healing, Anticancer
property. Aims and Objective A pharmaco-therapeutic
Study of Ashwagandha [Withania somnifera (Linn.) Dunal] and Amrita [Tinospora cordifolia
(Willd.) Miers] on Sandhivata w.s.r. to Osteo-Arthritis.Material and methods A total of 60 clinically diagnosed and confirmed
cases of sandhivaat were registered for the present clinical trial and randomly
divided into three group for this study.
Out of which 53 patients completed the course of treatment. The cases
were selected from the O.P.D of Government Ayurvedic College & Hospital and
L.N.J.P. Bone & Joint Super Specialty Hospital, Rajbanshinagar, Patna after
taking informed written consent.Criteria
for selection of patientsInclusion Criteria: -•Patients of Age group between 31 – 70 years and
Patient willing for the trial.•Patients have Selected signs and symptoms based on
both Ayurvedic and Modern context like, Sandhishula (pain), Sandhishotha
(swelling), Akunchana Prasarana Vedana (pain during flexion & extension),
Sandhigraha (stiffness), Sphutana (Crepitus), Sparsha-Asahyata (Tenderness)
etc. Exclusion Criteria: -• Less
than 31 year and more than 70 years.• Traumatic
injury of bone.• During
pregnancy.• Patient
having severe diseases like heart diseases, HIV, Hepatitis B and other severe
illness. Study design: A Randomized open clinical
study.Study type: Interventional and
diagnostic.Intervention model: Three group assignment. Allocation: Randomized ( By lottery process )Masking: open level.Primary purpose: Efficacy and safety of
selected drug.End point: Treatment.Sample size (number of subjects); 20 in
each group , ie 60 in the centre.Level of study: O.P.D & I.P.D level.•Ethical committee clearance: Before recruitment of
subjects in present clinical trial, approval from the approved by Institutional
ethics committee (Letter number- 1188 date- 30 September 2020) and has been
registered in Clinical Trial Registry India (CTRI) Under CTRI NO- CTRI / 2021
/10 /037554.Admistration
of drug: Clinically diagnosed and registered patients of
Sandhivaat (osteoarthritis) were randomly divided into the following three
group.GROUP- A: Patients were treated with
trial drug Ashwagandha churna – 6 gm / day in two divided doses.GROUP – B: Patients were treated with
trial drug Amrita Satva 1 gm/ day in two divided doses.GROUP- C: Patients were treated with
trial drug Ashwagandha Churna 6 gm with
Amrita Satva 1 gm/ day in two
divided doses. Method of Study 1.Consent: - A written informed consent was taken on prescribed
proforma before the inclusion of patient in trial. They were brief about merits
and demerits of research plan before taking consent.2.Clinical screening - A detailed case history proforma was specially
prepared for this purpose. All the mentioned points were recorded in this
proforma before initiating the trial. A. Pre Trial Screening :- This was done before the
administration of trial drug Complete medical history, Routine haematological
tests, Some of the biochemical tests, Ashtavidha and Dashavidha pariksha was also done . B. Follow up Screening :- OPD patients were called for follow up on
every 15th day to evaluate and to observe the effects or adverse effects of
treatment on their clinical status. The routine gradation of sign and symptoms were
recorded fortnightly. Duration of
clinical trial: 60 days Criteria for Assessment: All the
patients were assessed for relief in signs and symptoms and objective
parameters after the completion of trial. To give objectivity to subjective
symptoms grading/scoring system was adopted which is as follows: SandhiShula (pain) Score• No
pain - 0• Mild
pain - 1• Moderate
pain but no difficulty in walking - 2• Slight
difficulty in walking due to pain - 3• Severe
difficulty in walking – 4 Sandhishotha score:• No
swelling - 0• Slight
swelling - 1• Moderate
swelling - 2• Severe
Swelling -3 Akunchana Prasaranjanya Vedana
(pain during flexion & extension) score:• No
pain - 0• Pain
without winching of face - 1• Pain
with winching of face - 2• Prevent
complete flexion - 3• Does
not allow passive movement – 4 Sandhigraha (Stiffness) score:• No
Stiffness - 0• Mild
stiffness - 1• Moderate
stiffness - 2• Severe
difficulty due to stiffness - 3• Severe
stiffness more than 15 minutes and less than 45 minute. – 4.Sandhisphutan (Crepitus) score:• No
crepitus - 0• Palpable
crepitus - 1• Audible
crepitus – 2• Crepitus
on walking. -3Sparshashayata (Score):• No
tenderness - 0• Patient
says tenderness - 1• Winching
of face on touch - 2• Does
not allow to touch the joint – 3 LABORATORY INVESTIGATION• No
laboratory studies are diagnostic for O.A. Laboratory tests help in
differential differentiation diagnosis of OA with Rhumatic Arthritis, Gout,
Aamvata and Koshtrukashirsa .• The
haematological tests like Haemoglobin, total count of WBC, ESR, RBS, S. urea,
S. Creatinine, S. calcium, S. uric acid, RA factor, and CRP test are done for
routine examination and rule out any differential diagnosis.• Radiological
examination: - In the present study, Radiological examination was done before
start the clinical trial for diagnostic purpose, stage of diseases and
deformities. Statistical analysis:The information gathered regarding demographic data
is given in percentage. The scoring of criteria's assessment was analyzed
statistically in terms of B.T. (Before treatment), A.T. (After treatment), S.D.
(Standard Deviation) and S.E. (Standard Error). Paired "t" test was
carried out.The obtained results were interpreted as:• Insignificant
P>0.05• Significant
P<0.01, P<0.05• Highly
significant P<0.001. Result:
Clinical Improvement
EFFECT OF THERAPY
Group – A
TABLE- 1: The pattern of clinical recovery in various
subjective parameter of Sandhivaat (osteoarthritis).
Symptom
Mean Score
% Relief
S.D
S.E
‘t’
Value
‘p’
Value
B.T
A.T
Sandhishula
2.705
2.23
17.39
0.514
0.12
3.77
< .05
Sandhishotha
1.352
0.882
34.72
0.514
0.12
3.77
< .05
Akunchan Prasarana vedana
1.176
0.823
25
0.469
0.11
2.58
< .05
Sandhigraha
1.235
0.529
38.09
0.51
0.12
3.77
< .05
Sandhisphutana
1.152
1.41
7.69
0.332
0.08
1.46
>.05
Sparsha
Asahyata
0.352
0.176
50
0.39
0.09
1.85
>.05
EFFECT OF THERAPY
Group – B
TABLE- 2: The
pattern of clinical recovery in various subjective parameter of sandhivaat (osteoarthritis).
Symptom
Mean Score
% Relief
S.D
S.E
‘t’
Value
‘p’
Value
B.T
A.T
SandhiShula
2.66
2.22
14.58
0.501
0.11
3.28
<0.05
Sandhishotha
1.05
0.944
15.78
0.38
0.09
1.84
>0.05
Akunchan Prasarana vedana
1.33
0.83
33.33
0.51
0.12
3.68
<0.05
Sandhigraha
1.55
1.16
21.42
0.48
0.11
2.91
<0.05
Sandhisphutana
1.61
1.44
10.34
0.38
0.09
1.84
>0.05
Sparsha
Asahyata
0.27
0.16
40
0.32
0.76
1.45
>0.05
EFFECT OF THERAPY
Group – C
TABLE- 3: The pattern of clinical recovery in various
subjective parameter of sandhivaat (osteoarthritis).
Symptom
Mean Score
% Relief
S.D
S.E
‘t’
Value
‘p’
Value
B.T
A.T
Sandhishula
3.272
2.16
32.75
0.89
0.21
5.0
< .001
Sandhishotha
1.61
0.61
58.62
0.70
0.16
5.66
< .001
Akunchan Prasarana vedana
1.5
0.83
48.14
0.54
0.12
5.59
< .001
Sandhigraha
1.22
0.61
36.36
0.54
0.12
3.44
< .05
Sandhisphutana
2.05
1.88
10.81
0.44
0.10
2.10
> .05
Sparsha
Asahyata
0.55
0.27
72.00
0.54
0.12
3.09
< .05
Table-4 : Inter group Comparision in subjective
parameter of
sandhivaat (osteoarthritis).
Cardinal Symptoms
PERCENTAGE RELIEF
Group-A
Group-B
Group-C
%
Relief
“P”
Value
%
Relief
“P”
Value
%
Relief
“P”
Value
Sandhishula
17.39 %
< .05
14.58 %
<0.05
32.75%
< .001
Sandhishotha
34.72 %
< .05
15.78%
>0.05
58.62 %
< .001
Akunchana Prasarana vedana
25 %
< .05
33.33%
<0.05
48.14 %
< .001
Sandhigraha
38.09 %
< .05
21.42 %
<0.05
36.36 %
< .05
Sandhisphutana
7.69 %
>.05
10.34 %
>0.05
10.81 %
> .05
Sparshasahyata
50 %
>.05
40 %
>0.05
72 %
< .05
Discussion: Sandhivata is a dhatu kshyajanya vata vyadhi. It is
an age-related disorder. Based on symptoms, it can be correlated with
osteoarthritis. It is a multifactorial, non-inflammatory degenerative disorder.
The Pathological changes in major synovial joints are gradual thinning of
cartilage and osteophyte formation with irreversible degenerative changes.
According to the literary profile, Sandhivata is asadhya, or incurable in
nature. The medication can give only symptomatic relief.Ashwagandha and Amrita are Tikta Dravya having
vatahar, aganidipaniya, and Rasayana properties that redeem the vitalized vata
and degenerative changes in Sandhivata. Samprapti Ghataka : Sandhivaat is basically a dhatu kshayajanya
(degenerative) vata dominant disorder in the old age group. To counter balance
the basic pathology of the disorder, i.e., the degenerative process, drugs
which have Dipaniya, Rasayan, Brimhana, and Vatahar property are preferred for
treating Sandhivata.• The
drugs Ashwagandha and Amrita, having a unique combination of Ushna virya,
Madhur vipaka, and the above-mentioned properties, will definitely serve the
purpose.• Ashwagandha
have Tikta rasa with Balya karma, which differenciate it with other drug. Tikta
rasa has agnidipan and pachan property.• Amrita
have also Tikta rasa and agni dipaniya property due to Vayu and Aakash
mahabhut. Tikta Rasa has Vayu and Akasha Mahabhuta in dominance. Hence, it has
affinity towards the body elements like Asthi, having Vayu and Akasha Mahabhuta
in dominance, and also destroys khavagunaya of Sandhi due to its akasha
mahabhut, which is ashraya of vitalized vata.• Ashwagandha
and Amrita are Ushna, and tikta, laghu rasayan dravya, which clean closed
channels to provide nutrition to every cell of the body and improve digestion
(Dhatvagni) and metabolism, which improve the structural and functional pattern
of dhatu. As a result, Asthi dhatu and Majja dhatu get stable and get kshaya of
their respective dhatus, which will be decreased. It can be said that it slows
down the degenerative process. Ashwagandha and Amrita have vatashamak property
due to ushna virya. So it reduces the cardinal symptom of Sandhivata. • Ashwagandha
and Amrita
are both drugs that have madhur vipaka. In Sutraasthan, Acharya Vaghbhat states
, Rasa and vipaka have the same therupetic action, so both have excellent
efficacy and Vatshamak property due to Madhur vipaka.• Ashwagandha
has Guna Snigdh , Virya ushna and Vipaka Madhur, which help in pacifying aggrevated vata
and Amrita has also virya ushna and vipaka madhur, which help in control
elevated vata dosha.Conclusion: Comparing the symptomatic improvement in
all group ,a statistically significant difference was found in all three groups
on compiling the effect of therapy. It may be said that the Ashwagandha of
Group-A is more efficient than that of Group-B. (Amrita). However, Group-C
(Ashwagandha + Amrita) was shown to be more effective in treating the patients
than either Group-A or Group-B. The trial drug has given promising results by
showing improvement in the signs and symptoms of Sandhivata. This study overall
conclude that both drug are Ashwagandha and Amrita are effective in sandhivaat.
These drugs have zero side effects when used in a therapeutic setting. The
therapeutic results obtained in the current study are satisfactory. Their
production costs are low, making them affordable to any social group. There for
Ashwagandha and Amrita are used as a preventative and therapeutic treatment of
Sandhivata. References1. The charaka samhita of Agnivesh,
vidyoti
hindi commentary by Pt. Kashi Nath Shastri and Dr. Gorakh Nath sastri,13th
edition,1986, chaukhamba bharti academy.
varanasi,
sutraasthan 9/72. Encyclopaedia of Economic Botany,
vikash
kumarsharma, sunil kr sehanai, volume-4, first edition-2012,
Published
by-campus book international, 4831/24.prahlad street, ansari road,
New
–Delhi 1100023. Mishra LC, Singh BB, Dagenais S. Scientific basis for the
therapeutic use of Withania somnifera (Ashwagandha): a review. Altern Med Rev.
2000 Aug:5(4):334-46. PMID: 10956379. 4. Iuvone T, Esposito G, Capasso F, Izzo A. Induction of nitric
oxide synthase expression by Withania somnifera in macrophages. Life Sci
2003:72:1617- 1625.5. A. Kumar, S.K. Kulkarni. Effect of BR-16A (Mentat), a
polyherbal formulation on drug-induced catalepsy in mice. Indian J. Exp. Biol.
44(1): 45-48 (2006).Prakash J, Gupta SK, Dinda AK. Withania somnifera root
extract prevents DMBA-induced squamous cell carcinoma of skin in Swiss albino
mice. Nutr Cancer 2002:42:91-97.6. 12 Jayaprakasam B, Zhang Y, Seeram N, Nair M. Growth
inhibition of tumor cell lines by withanolides from Withania somnifera leaves.
Life Sci 2003:74:125-132.7. N.P. Visavadiya, A.V. Narasimhacharya. Hypocholesteremic and
antioxidant effects of Withania somnifera (Dunal) in hypercholesteremic rats.
Phytomedicine.8. Bhaw prakash nighantu3/1-59. Kaushik sutra 22-1-5010. GuduchiswasotiktAkashayoshna ……..kanduvisharpnaashini. dhan.ni.
guduchyadivarga.1/5-711. M.p nighantu. abhyadi varga.12. Chhinnayah swarasam vapi………..divyarupobhawennarah.13. Guduchiswarasa…………. payayattadhalimake.sodhal Ni Hallimak14. Vasak ewaraasam vaapi
Gudhuchya Rasamev cha. Sodhal Ni. Vatajanya Raktapradar.15. Guduchi madhura pake ……….kasan rasayani. Kaidev Ni Aushadhi
.varga1/9-1016. Sangrahini kashayoshana …………Hridrogavatanut.17. BhavaprAkashnighu. Guduchayadi varga18. Gudhuchigurashnavirya…………bharmaharini Rajnighantu guduchayadivarga19. Kwatho jirnaJwaramHanti Guduchya Pippaliyutam. Shar Samh.M.K 2/4420. Amritairandvasanam..............Vataraktami
jayetdhruwam.Shar.Sam.M.K.2/13321. Amritaya rasah kshoudrayuktah Sarwapramchjit Shar Sam.M.K.1/722. Kamlayam...... Rasoathwa jayatikamlam.Shar.Sam. M.K.1/9 21.
Bhav Prakashni.Guduchyadi Varga.23. Madhuk Madhuparni Prishniparni Ambasthaki
Samanga............... Sandhaniyani bhawanti.24. R. Mehra, T. Naved, M. Arora, S. Madan, Standardization and
evaluation offormulation parameters of
Tinospora cordifolia tablet, J. Adv. Pharm. Educ. Res. 3 (2013) 440–449.25. G. Abiramasundari,
K.R. Sumalatha, M. Sreepriya, Effects of Tinospora cordifolia (Menispermaceae)
on the proliferation, osteogenic differentiation and mineralization of
osteoblast model systems in-vitro, J. Ethnopharmacol. 141 (2012) 474–480.26. Chemistry and
pharmacology of ayurvedic medicinal plants by VD MUKUND SABNIS, B.A.M.S,MD
CHAUKHAMBA AMARABHARTI PRAKASHAN. POST
BOX NO-1138,VARANASI.27. Anonymous, the Ayurvedic Pharmacopoeia of India. Part I.
first ed.. Vol. 1, Department of AYUSH, Ministry of Health and FW, New Delhi
(2001) 53-55.28. A.D. Chougale, V.A. Ghadyale, S.N. Panaskar, A.U. Arvindekar,
Alpha-glucosidase inhibition by stem extract of Tinospora cordifolia, J. Enzym.
Inhib. Med. Chem. 24 (2009) 998–1001.29. M.B. Patel, S.M. Mishra, Magnoflorine from Tinospora
cordifolia stem inhibits α-glucosidase and its antiglycemic in rats, J. Funct.
Foods 4 (2012) 79–86.30. D. Singh, P.K. Chaudhuri, Chemistry and pharmacology of
Tinospora cordifolia, Nat. Prod. Commun.
12 (2017) 299–308.31. P.P.M. Stanely, V.P. Menon, G. GunaseKharam, Hypolipidaemic
action of Tinospora cordifolia roots in alloxan-induced diabetic rats, J.
Ethnopharmacol. 64 (1999) 53–57. 32. D.N.K. Sarma, R.L. Khosa, J.P.N. Chaurasia, M. Sahai,
Antistress activity of Tinospora cordifolia and Centella asiatica extracts,
Phytother Res. 10 (1996).33. P. Baghel, Plant of versatile vroperties of Tinospora
cordifolia (Guduchi), IJAIR 5 (2017) 751–753.34. B. Sharma, R. Dabur, Protective effects of Tinospora
cordifolia on hepatic and gastrointestinal toxicity induced by chronic and
moderate alcoholism, Alcohol 51 (2016) 1–10.35. R. Jeyachandran, T.F. Xavier, S.P. Anand, Antibacterial
activity of stem extracts of Tinospora cordifolia (willd) hook, Anc. Sci. Life.
Res. 25 (2003) 40–43.36. A.S. Narayanan, S.S. Raja, K. Ponmurugan, S.C. Kandekar, K.
Natarajaseenivasan, Maripandi, Q.A.
Mandeel, Antibacterial activity of selected medicinal plants against multiple
antibiotic resistant uropathogens, Benef. Microbes 2 (2011) 235–24337. T. Shanbhag, S. Shenoy, M.C. Rao, Wound healing profile of
Tinospora cordifolia, Indian Drugs 42 (2005) 217–221.38. H. Ali, S. Dixit, Extraction optimization of Tinospora
cordifolia and assessment of the anticancer activity of its alkaloid palmatine,
Sci. World J 28 (2013) 1–10.39. R. Verma, H.S. Chaudhary, R.C. Agrawal, Evaluation of
antcarcinogenic and antmutagenic effect of Tinospora cordifolia in experimental
animals, J. Chem.Pharm. Res. 3 (2011) 877–881.40. The Ayurvedic Formulary of India. Part‑1. 2nd ed. New Delhi:
Controller of Publications, Ministry of Health and Family Welfare, Govt. of
India: 2003. p. 560.41. Nagarjuna. In: Sharma HS, editor. Rasendra Mangalam of
Nagarjuna. 3\112. Varanasi: Choukhamba Orientalia: 2008. p. 84.42. Shastri B, editor. Commentary Vidhyotani of Shastri Laxmipati
sastri on Yogaratnakara . reprint-2021,: Choukhamba
prakashan,:Varanasi 2021 p. 383 43. Sharma H. Rasa Yoga Sagara. Reprint ed. Varanasi: Chaukhamba
Krishnadas Academy: 2004. p. 378.44. Acharya YT. Siddha Yoga Sangraha. Rajyakshma
Urahkshatadhikar. 13th ed., Ch. 14. Nagpur: Shri Baidhnath Ayurved Bhavan Ltd.:
2008. p. 83‑4.45. Seasonal variations in physicochemical profiles of Guduchi
Satva (starchy substance from Tinospora cordifolia [Willd.] Miers),Rohit
Sharma, Hetal Amin1, Galib R, P. K. PrajapatiDepartments of Rasashastra and
Bhaishajya Kalpana, and 1Basic Principles, I.P.G.T. and R.A., Gujarat Ayurved
University, Jamnagar, Gujarat, India.46. Sharma R, Harisha CR, Galib R, Patgiri BJ, Prajapati
PK.Quantitative estimation of Satva extracted from different stem sizes of
Guduchi (Tinospora cordifolia (Willd.) Miers. J Pharm Sci Innov 2012:1:38‑40. 47. Charaka Samhita of Agnivesha, Ambika Data Sartri:
Kalpasthana: Madanakalpa. Reprint ed. ch. 1. Ver.10. Varanasi: Chaukhamba
Orientalia: 2011.48. Acharya YT. Sushruta Samhita of Sushruta: Sutrasthana:
Bhumipravibhagiya. Reprint ed. ch. 37. Ver. 5. Varanasi: Chaukhamba Sanskrita
Sansthana: 2010. .49. Sharma P.V, Drvyaguna Vijñana, Vol - I, Chaukhamba Bharati
Academy, Varanasi, 1994: 48.50. Bhava Mishra, Bhavaprakasa, Edt. Mishra Pt.Brahma Shankar,
Part-1, Guduchyadi Varga, Chaukhamba publication, Varanasi, 1988: 270.51. Ayurvedic Formulary of India, Part – I, ISMH, G.O.I,
2003,14:1: 163.52. Sharma H. Rasa Yoga Sagara. Reprint ed. Varanasi: Chaukhamba
Krishnadas Academy: 2004. p. 378.53. Shastri B, editor. Commentary Vidhyotani of Shastri Laxmipati
sastri on Yogaratnakara reprint-2021 ,: Choukhamba
prAkashan,:Varanasi 2021 p. 38354. Reddy KR. Ausadha Kalpana. Bhaishajya Kalpana Vijnanam. 2nd
ed. Ch. 4.Varanasi: Chaukhamba Samskrita Bhawan: 2005. p. 234.55. Hiremath SG. Satva Kalpana. A Text Book Bhaishajya Kalpana.
2nd revised ed. Part Ch. 19. Varanasi: Chaukhamba Orientalia: 2005. p. 220.56. Ayurvedic pharmacopoeia of India, part-1, volume-VI, appendix
2.4.1, pg no 275. 57. Laboratory Guide for the Analysis of Ayurveda and Siddha
Formulations, CCRAS,2010.58. BHĀVAPRAKĀSA OF ŚRĪ
BHĀVAMISRA By Bhisagratna Pandit
Śrī Brahma Sankara Miśra, Publishers: Chaukhambha Sanskrit
Sansthan, Post Box. No. 1139 Varanasi-221001 (India), ninthedition, page no-265.59. Ashtanga Hridaya composed by Vagbhata with the commentaries
Sarvanga sundari of Arunadatta and
Ayurveda Rasayana of Hemadri, Chaukhambha Orientalia, Varanasi. Sutraasthan 19/8-14.60. Ashtanga Hridaya composed by Vagbhata with the commentaries
Sarvanga sundari of Arunadatta and Ayurveda Rasayana of Hemadri, Chaukhambha
Orientalia, Varanasi. Sutraasthan 20/36-41 .61. The charaka samhita of Agnivesh,vidyoti hindi commentary by
Pt. Kashi Nath Shastri and Dr. Gorakh Nath sastri,13th edition,1986, chaukhamba
bharti academy.varanasi, Sutraasthan 11/48.62. Sushruta Samhita of maharshi Sushruta:by Kviraj Ambikadutta
Sastri : Reprint ed 2018. Varanasi: Chaukhamba Sanskrita Sansthana:
sharirasthan 6/3.63. Sushruta Samhita of maharshi Sushruta:by Kviraj Ambikadutta
Sastri : Reprint ed 2018. Varanasi: Chaukhamba Sanskrita Sansthana:
Nidhanasthan 1/17-18.64. Sushruta Samhita of maharshi Sushruta:by Kviraj Ambikadutta
Sastri : Reprint ed 2018. Varanasi: Chaukhamba Sanskrita Sansthana:
Sutraasthan 21/5.65. The charaka samhita of Agnivesh,vidyoti hindi commentary by
Pt. Kashi Nath Shastri and Dr. Gorakh Nath sastri,13th edition,1986, chaukhamba
bharti academy.varanasi, sutraasthan.66. The charaka samhita of Agnivesh,vidyoti hindi commentary by
Pt. Kashi Nath Shastri and Dr. Gorakh Nath sastri,13th edition,1986, chaukhamba
bharti academy.varanasi, sutraasthan 1/59,and
12/4.67. Robbins and Cotran Pathologic Basis of Disease Eighth
Edition. page no-123668. Harrison's, Principles of Internal Medicine, 18th edition,
Volume 2nd McGraw- Hill, Medical
Publishing Division, New York. page no- 2828,2829.69. Harrison's, Principles of Internal Medicine, 18th edition,
Volume 2nd McGraw- Hill, Medical Publishing Division, New York. page no- 2830 .70. Harrison's, Principles of Internal Medicine, 18th edition,
Volume 2nd McGraw- Hill, Medical
Publishing Division, New York. page no- 2832.71. Harrison's, Principles of Internal Medicine, 18th edition,
Volume 2nd McGraw- Hill,Medical
Publishing Division, New York. page no- 2831.72. Robbins and Cotran Pathologic Basis of Disease Eighth Edition.
page no-123673. Osteoarthritis and the metabolic syndrome: more evidence that
the etiology of OA is different in
men and women by K.M. Huffman and W.E.
Kraus PMC 2013 APR 30, PMCID:
PMC363948574. Davidson's Principles and Practice of Medicine 21st Edition, musculoskeletal
diseases. Page no-1085 75. Current Medical Diagnosis & Treatment 2021 Special India
Edition Maxine A. Papadakis Stephen J.
Mcphee Associate Editor Michael W. Rabow Mc Graw Hill Lange, Page No-852,
Chap-20.
Dharmendra Mondal1,
Raman Ranjan2, Alok Ranjan3, Subhash Chandra4,
Ganesh Prasad Gupta5.
1Ayurvedic
Medical Officer, Government of Bihar.
2Assistant Professor,
Dravyaguna Department, Government Ayurvedic College, Patna.
3 Assistant Professor,
Dravyaguna Department, Government Ayurvedic College, Patna.
4Director, L.N.J.P,
Bone & Joint Superspeciality Hospital, Rajbanshi Nagar, Patna, Bihar
5 Associate Professor,
Dravyaguna Department, Government Ayurvedic College, Patna.
ABSTRACT-Sandhivata is a
dhatu kshyajanya vata vyadhi. It is an age-related disorder. Based on symptoms,
it can be correlated with osteoarthritis. It is a multifactorial,
non-inflammatory degenerative disorder. Vata is the main factor responsible for
producing Sandhivata, and its description is widely narrated in almost all the
classical texts. In the present study named as A pharmaco-therapeutic study of
Ashwagandha [withania somnifera (Linn.) Dunel] and Amrita [Tinospora
cardifolia(wild.) miers] on sandhivaat w.s.r to Osteo-Arthritis, an attempt has
been made in the management of sandhivaat. This present study aim to find a
method of treatment to symptomatic relief without any side effect. Ashwagandha
and Amrita are Tikta Dravya having vatahar, aganidipaniya, and Rasayana
properties that redeem the vitalized vata and degenerative changes in
Sandhivata. The present study is taken upto evaluate the effect of Ashwagandha
churna (Group-A), Amrita satva (Group-B) and combine effect of both Ashwagandha
and Amrita satva (Group-C) and compaire the effect of all three groups. The
Ashwagandha of Group-A is more efficient than that of Group-B. (Amrita).
However, Group-C (Ashwagandha + Amrita) was shown to be more effective in
treating the patients than either Group-A or Group-B. The trial drug has given
promising results by showing improvement in the signs and symptoms of
Sandhivata.
सारांश- (संधिवात एक 'धातु क्षयजन्य वात व्याधि' है। यह उम्र से संबंधित एक विकार है। इसके लक्षणों के आधार पर इसकी तुलना
ऑस्टियोआर्थराइटिस से की जा सकती है। यह एक बहु-कारकीय, गैर-सूजन-संबंधी, अपक्षयी विकार (multi-factorial, non-inflammatory degenerative disorder) है। वात संधिवात उत्पन्न करने का मुख्य कारक है, और इसका वर्णन लगभग सभी शास्त्रीय ग्रंथों में व्यापक रूप से किया गया है।'A
pharmaco-therapeutic study of Ashwagandha [withania somnifera(Linn.) Dunel] and
Amrita [Tinospora cardifolia(wild.) miers] on sandhivaat w.s.r to
Osteo-Arthritis' नामक इस अध्ययन में, संधिवात के प्रबंधन के लिए एक प्रयास किया गया है। इस अध्ययन का उद्देश्य
बिना किसी दुष्प्रभाव के लक्षणों से राहत के लिए उपचार का एक तरीका खोजना है।
अश्वगंधा और अमृता 'तिक्त द्रव्य' हैं, जिनमें वातहर, अग्निदीपनीय और रसायन गुण होते हैं, जो संधिवात में वात और अपक्षयी परिवर्तनों को ठीक करते हैं।यह अध्ययन
अश्वगंधा चूर्ण (समूह-ए), अमृता सत्व (समूह-बी) और अश्वगंधा और अमृता सत्व (समूह-सी) के संयुक्त
प्रभाव का मूल्यांकन और तीनों समूहों के प्रभाव की तुलना करने के लिए किया गया है।
समूह-ए (अश्वगंधा) का प्रभाव समूह-बी (अमृता) से अधिक प्रभावशाली है। हालांकि, समूह-सी (अश्वगंधा + अमृता) को समूह-ए या समूह-बी की तुलना में रोगियों के
इलाज में अधिक प्रभावी दिखाया गया है। परीक्षण दवा ने संधिवात के लक्षणों और
संकेतों में सुधार दिखाकर आशाजनक परिणाम दिए हैं।)
INTRODUCTIONIntroduction- Health is the supreme foundation for
the achievement of a happy life. Humans must comprehend the ideal concept of
health and dhatu samya in order to accomplish their primary goal in life, which
is to achieve ‘Hitayu’ and ‘Sukhayu’.Due to the modernization and resulting
sedentary lifestyle, younger and older people are complaining of different
"Vatika disorders". In Ayurveda, the decade wise ageing process is
described. There are two categories of ageing, kalaja and akalaja. All khatu
undergoes Kshaya in vridhavastha, which results in vata prakopa and makes the
person susceptible to a wide range of diseases. Sandhivata
stands at the top of the list, and it is described under Vata vyadhi in all the
Samhita and Sangraha Grantha. Among the three doshas, Vata is responsible for
all chestha. Acharya Charak was the first person who described the disease
separately named "Sandhigata anila", but it is not included under the
80 types of nanatmaja vyadhi . Acharya Vagabhatta has also considered Vata
vyadhi as a maharoga. Sandhivata is a Vata Vyadhi, occurring when the patient
attains the Vatika phase of life, i.e. after 50 years of age. As in this
period, Vata Dosha is predominant, mainly occurring due to Prakopa of Vata.
This Vata Prakopa can occur for either of three reasons.• Dhatukshyajanya
Vata Prakopa• Swanidana
Sevanajanya Vata Prakopa• Avaranjanya
Vata Prakopa. Osteoarthritis is one of the most common arthritic conditions increasing
in the elderly population. It is a slow-progressing degenerative joint disease.
Many studies reported that these degenerative changes in joints arise from the
age of 30 years by the age of 70 years, 80% of the people may have radiographic
evidence of Osteoarthritis although only 25% may have symptoms. The symptoms,
such as pain and inflammation, appear in middle age. The association with ageing
is strong: the prevalence of OA increases exponentially beyond the age of 50,
and about 80% to 90% of individuals have evidence of the disease by age 65.
Osteoarthritis is a major cause of morbidity and disability, limiting activity
and impairing quality of life, especially among the elderly. The primary
complaints of patients with osteoarthritis are pain and difficulty in movement
of joints.By
considering all the described facts, it can be concluded that the complete cure
of the disease still has the status of a miracle. So, we have here made an
effort to find a safe and complete solution for the disease with the help of
Ayurvedic medicine, which is described in the context of Sandhivata chikitsa. According to
Bhawapraksh, Ashwagandha minimizes the Vata (anila) Dosha, shoth, and kshaya
due to its ushna virya, Balya, and Rasayan property. Its Doshakarm is Kapha-Vata
shamak. Ashwagandha has pharmacological action like Anti inflammatory activity,
Immunomodulation and Hematopoiesis, Adaptogenic Action, Antiparkinsonian properties,
Anti-Malignant Activity, Anti-Aging, Hypolipidemic effect. According to Acharya
charak, Amrita have Vatahar property and its Doshakarm is Tridosh shamak. Amrita has pharmacological action like
Anti-osteoporotic effects, Immunomodulatory activity, Antidiabetic activity,
Hypolipidemic effect, Antistress activity, Hepatic disorder, Wound healing, Anticancer
property. Aims and Objective A pharmaco-therapeutic
Study of Ashwagandha [Withania somnifera (Linn.) Dunal] and Amrita [Tinospora cordifolia
(Willd.) Miers] on Sandhivata w.s.r. to Osteo-Arthritis.Material and methods A total of 60 clinically diagnosed and confirmed
cases of sandhivaat were registered for the present clinical trial and randomly
divided into three group for this study.
Out of which 53 patients completed the course of treatment. The cases
were selected from the O.P.D of Government Ayurvedic College & Hospital and
L.N.J.P. Bone & Joint Super Specialty Hospital, Rajbanshinagar, Patna after
taking informed written consent.Criteria
for selection of patientsInclusion Criteria: -•Patients of Age group between 31 – 70 years and
Patient willing for the trial.•Patients have Selected signs and symptoms based on
both Ayurvedic and Modern context like, Sandhishula (pain), Sandhishotha
(swelling), Akunchana Prasarana Vedana (pain during flexion & extension),
Sandhigraha (stiffness), Sphutana (Crepitus), Sparsha-Asahyata (Tenderness)
etc. Exclusion Criteria: -• Less
than 31 year and more than 70 years.• Traumatic
injury of bone.• During
pregnancy.• Patient
having severe diseases like heart diseases, HIV, Hepatitis B and other severe
illness. Study design: A Randomized open clinical
study.Study type: Interventional and
diagnostic.Intervention model: Three group assignment. Allocation: Randomized ( By lottery process )Masking: open level.Primary purpose: Efficacy and safety of
selected drug.End point: Treatment.Sample size (number of subjects); 20 in
each group , ie 60 in the centre.Level of study: O.P.D & I.P.D level.•Ethical committee clearance: Before recruitment of
subjects in present clinical trial, approval from the approved by Institutional
ethics committee (Letter number- 1188 date- 30 September 2020) and has been
registered in Clinical Trial Registry India (CTRI) Under CTRI NO- CTRI / 2021
/10 /037554.Admistration
of drug: Clinically diagnosed and registered patients of
Sandhivaat (osteoarthritis) were randomly divided into the following three
group.GROUP- A: Patients were treated with
trial drug Ashwagandha churna – 6 gm / day in two divided doses.GROUP – B: Patients were treated with
trial drug Amrita Satva 1 gm/ day in two divided doses.GROUP- C: Patients were treated with
trial drug Ashwagandha Churna 6 gm with
Amrita Satva 1 gm/ day in two
divided doses. Method of Study 1.Consent: - A written informed consent was taken on prescribed
proforma before the inclusion of patient in trial. They were brief about merits
and demerits of research plan before taking consent.2.Clinical screening - A detailed case history proforma was specially
prepared for this purpose. All the mentioned points were recorded in this
proforma before initiating the trial. A. Pre Trial Screening :- This was done before the
administration of trial drug Complete medical history, Routine haematological
tests, Some of the biochemical tests, Ashtavidha and Dashavidha pariksha was also done . B. Follow up Screening :- OPD patients were called for follow up on
every 15th day to evaluate and to observe the effects or adverse effects of
treatment on their clinical status. The routine gradation of sign and symptoms were
recorded fortnightly. Duration of
clinical trial: 60 days Criteria for Assessment: All the
patients were assessed for relief in signs and symptoms and objective
parameters after the completion of trial. To give objectivity to subjective
symptoms grading/scoring system was adopted which is as follows: SandhiShula (pain) Score• No
pain - 0• Mild
pain - 1• Moderate
pain but no difficulty in walking - 2• Slight
difficulty in walking due to pain - 3• Severe
difficulty in walking – 4 Sandhishotha score:• No
swelling - 0• Slight
swelling - 1• Moderate
swelling - 2• Severe
Swelling -3 Akunchana Prasaranjanya Vedana
(pain during flexion & extension) score:• No
pain - 0• Pain
without winching of face - 1• Pain
with winching of face - 2• Prevent
complete flexion - 3• Does
not allow passive movement – 4 Sandhigraha (Stiffness) score:• No
Stiffness - 0• Mild
stiffness - 1• Moderate
stiffness - 2• Severe
difficulty due to stiffness - 3• Severe
stiffness more than 15 minutes and less than 45 minute. – 4.Sandhisphutan (Crepitus) score:• No
crepitus - 0• Palpable
crepitus - 1• Audible
crepitus – 2• Crepitus
on walking. -3Sparshashayata (Score):• No
tenderness - 0• Patient
says tenderness - 1• Winching
of face on touch - 2• Does
not allow to touch the joint – 3 LABORATORY INVESTIGATION• No
laboratory studies are diagnostic for O.A. Laboratory tests help in
differential differentiation diagnosis of OA with Rhumatic Arthritis, Gout,
Aamvata and Koshtrukashirsa .• The
haematological tests like Haemoglobin, total count of WBC, ESR, RBS, S. urea,
S. Creatinine, S. calcium, S. uric acid, RA factor, and CRP test are done for
routine examination and rule out any differential diagnosis.• Radiological
examination: - In the present study, Radiological examination was done before
start the clinical trial for diagnostic purpose, stage of diseases and
deformities. Statistical analysis:The information gathered regarding demographic data
is given in percentage. The scoring of criteria's assessment was analyzed
statistically in terms of B.T. (Before treatment), A.T. (After treatment), S.D.
(Standard Deviation) and S.E. (Standard Error). Paired "t" test was
carried out.The obtained results were interpreted as:• Insignificant
P>0.05• Significant
P<0.01, P<0.05• Highly
significant P<0.001. Result:
Clinical Improvement
EFFECT OF THERAPY
Group – A
TABLE- 1: The pattern of clinical recovery in various
subjective parameter of Sandhivaat (osteoarthritis).
|
Symptom |
Mean Score |
% Relief |
S.D |
S.E |
‘t’ Value |
‘p’ Value |
|
|
B.T |
A.T |
||||||
|
Sandhishula |
2.705 |
2.23 |
17.39 |
0.514 |
0.12 |
3.77 |
< .05 |
|
Sandhishotha
|
1.352 |
0.882 |
34.72 |
0.514 |
0.12 |
3.77 |
< .05 |
|
Akunchan Prasarana vedana |
1.176 |
0.823 |
25 |
0.469 |
0.11 |
2.58 |
< .05 |
|
Sandhigraha
|
1.235 |
0.529 |
38.09 |
0.51 |
0.12 |
3.77 |
< .05 |
|
Sandhisphutana |
1.152 |
1.41 |
7.69 |
0.332 |
0.08 |
1.46 |
>.05 |
|
Sparsha
Asahyata |
0.352 |
0.176 |
50 |
0.39 |
0.09 |
1.85 |
>.05 |
EFFECT OF THERAPY
Group – B
TABLE- 2: The
pattern of clinical recovery in various subjective parameter of sandhivaat (osteoarthritis).
|
Symptom |
Mean Score |
% Relief |
S.D |
S.E |
‘t’ Value |
‘p’ Value |
|
|
B.T |
A.T |
||||||
|
SandhiShula |
2.66 |
2.22 |
14.58 |
0.501 |
0.11 |
3.28 |
<0.05 |
|
Sandhishotha
|
1.05 |
0.944 |
15.78 |
0.38 |
0.09 |
1.84 |
>0.05 |
|
Akunchan Prasarana vedana |
1.33 |
0.83 |
33.33 |
0.51 |
0.12 |
3.68 |
<0.05 |
|
Sandhigraha
|
1.55 |
1.16 |
21.42 |
0.48 |
0.11 |
2.91 |
<0.05 |
|
Sandhisphutana |
1.61 |
1.44 |
10.34 |
0.38 |
0.09 |
1.84 |
>0.05 |
|
Sparsha
Asahyata |
0.27 |
0.16 |
40 |
0.32 |
0.76 |
1.45 |
>0.05 |
EFFECT OF THERAPY
Group – C
TABLE- 3: The pattern of clinical recovery in various
subjective parameter of sandhivaat (osteoarthritis).
|
Symptom |
Mean Score |
% Relief |
S.D |
S.E |
‘t’ Value |
‘p’ Value |
|
|
B.T |
A.T |
||||||
|
Sandhishula |
3.272 |
2.16 |
32.75 |
0.89 |
0.21 |
5.0 |
< .001 |
|
Sandhishotha
|
1.61 |
0.61 |
58.62 |
0.70 |
0.16 |
5.66 |
< .001 |
|
Akunchan Prasarana vedana |
1.5 |
0.83 |
48.14 |
0.54 |
0.12 |
5.59 |
< .001 |
|
Sandhigraha
|
1.22 |
0.61 |
36.36 |
0.54 |
0.12 |
3.44 |
< .05 |
|
Sandhisphutana |
2.05 |
1.88 |
10.81 |
0.44 |
0.10 |
2.10 |
> .05 |
|
Sparsha
Asahyata |
0.55 |
0.27 |
72.00 |
0.54 |
0.12 |
3.09 |
< .05 |
Table-4 : Inter group Comparision in subjective
parameter of
sandhivaat (osteoarthritis).
|
Cardinal Symptoms |
PERCENTAGE RELIEF |
|||||
|
Group-A |
Group-B |
Group-C |
||||
|
% Relief |
“P” Value |
% Relief |
“P” Value |
% Relief |
“P” Value |
|
|
Sandhishula |
17.39 % |
< .05 |
14.58 % |
<0.05 |
32.75% |
< .001 |
|
Sandhishotha |
34.72 % |
< .05 |
15.78% |
>0.05 |
58.62 % |
< .001 |
|
Akunchana Prasarana vedana |
25 % |
< .05 |
33.33% |
<0.05 |
48.14 % |
< .001 |
|
Sandhigraha |
38.09 % |
< .05 |
21.42 % |
<0.05 |
36.36 % |
< .05 |
|
Sandhisphutana |
7.69 % |
>.05 |
10.34 % |
>0.05 |
10.81 % |
> .05 |
|
Sparshasahyata |
50 % |
>.05 |
40 % |
>0.05 |
72 % |
< .05 |
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