Dharmendra Mondal1, Raman Ranjan2, Alok Ranjan3, Subhash Chandra4, Ganesh Prasad Gupta5.
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।)
Keywords :Sandhivata,Osteoarthritis,Ashwagandha (Withania somnifera),Amrita (Tinospora cordifolia),Ayurvedic Pharmacotherapy, Vata Vyadhi, Degenerative Joint Disease, Rasayana Therapy
Introduction
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.
• Swanidana Sevanajanya Vata Prakopa
• Avaranjanya Vata Prakopa.
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.
Materials 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 patients
Inclusion 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: -
• 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
• 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:
• Slight swelling - 1
• Moderate swelling - 2
• Severe Swelling -3
Akunchana Prasaranjanya Vedana
(pain during flexion & extension) score:
• 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:
• 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:
• Palpable crepitus - 1
• Audible crepitus – 2
• Crepitus on walking. -3
Sparshashayata (Score):
• 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 |
Results and 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.
Conclusion
The present clinical study
demonstrates that Ashwagandha (Withania somnifera) and Amrita (Tinospora
cordifolia) are effective Ayurvedic drugs in the management of Sandhivata
(Osteoarthritis). Both drugs possess Vata-shamaka, Rasayana, and Agnidipaniya
properties which help in reducing the pathological process associated with dhatu
kshaya and vata prakopa. The clinical findings of the trial showed significant
improvement in major symptoms such as Sandhishula (pain), Sandhishotha
(swelling), Sandhigraha (stiffness), and Akunchana-Prasarana Vedana (pain
during movement).
Comparative evaluation among the
three groups revealed that Ashwagandha alone (Group-A) produced better
symptomatic relief than Amrita alone (Group-B). However, the combined therapy
of Ashwagandha and Amrita (Group-C) showed the maximum therapeutic effect,
indicating a synergistic action of the two drugs in controlling the
degenerative and Vata-dominant pathology of Sandhivata.
The trial drugs were found to be safe,
economical, and free from significant adverse effects, making them suitable for
long-term management of degenerative joint disorders. Therefore, the combined
use of Ashwagandha and Amrita may be considered a promising and effective
Ayurvedic therapeutic approach for Sandhivata (Osteoarthritis). Further studies
with larger sample size and longer duration are recommended to validate these
findings scientifically.
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