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।)
INTRODUCTION
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.
• 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
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: -
• 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. -3
Sparshashayata (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).
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.
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