A Comparative Study to Evaluate Effectiveness of "Pathya Counselling"in Management of "Amavata (Rheumatoid Arthritis)"

Amavata is vata kapha dominant tridhoshaj disease caused mainly due to viruddhara (incompatible diet) and mandagni (low digestive fire). Viruddhara and mandagni  leads to formation of Apakwa rasa(partially digested rasa dhatu); manifesting as Ama. Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology marked by a symmetric, peripheral polyarthritis. It is the most common form of chronic inflammatory arthritis and often results in joint damage and physical disability.RA affects approximately 0.5-1% of the adult population worldwide and about 0.1-0.4% Indian population. The treatment in RA comprises the early use of disease-modifying antirheumatic drugs DMARDs and corticosteroids for induction of remission. These drugs have serious side effects like GI upset, nausea, stomatitis, rash, alopecia, hepatotoxicity, acute pneumonitis, renal impairment, hypertension, osteoporosis, etc. The term “Pathya†is derived from the term –“Patha†(which means “srotasâ€or bodily minute channels). Pathya(wholesome) refers to the diet and regimen which is conducive to the bodily channels and is pleasant to  mind. Hence, it is widely accepted by the patient’s body and the patient himself. Pathya is an important adjuvant with drugs in Ayurvedic management of disease.Though, Pathya is not a substitute of medicine, it changes the landscape of the disease as an addition to commonly prescribed Ayurvedic medications.In every consultation, an Ayurvedic doctor pays heed in explaining the wholesome and unwholesome diet and lifestyle regime to the patient along with the medications. Patients are also concerned about appropriate diet; since Pathya Counselling is equally important and give promising results when combined with therapeutic drugs as to be done in this study. As there is scarcity of reliable scientific study on effectiveness of Pathya Counselling in management of Amavata (Rheumatoid arthritis), present study has been planned to observe, collect, collate, and analyze the effects of Pathya Counselling in patients of Amavata.

Aim of the study is to evaluate effectiveness of “Pathya Counselling†in management of “Amavata (Rheumatoid arthritis)â€. Primary Objective is to offer “Pathya Counselling†training along with commonly prescribed Ayurvedic treatment in patients of Amavata (Rheumatoid arthritis). Secondary Objective is to evaluate the effect of “Pathya Counselling†in management of Amavata. Type of study is Interventional. Study Design is Randomized Clinical Trial. Study setting is Single centered (O.P.D. / I.P.D. in Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi). Duration of trial is 7 weeks (49 Days). Enrolled patients in Group-A and Group-B will be examined for a 7 day follow-up after completion of intervention at Day 42.

Sample size is 30 patients.  Individuals presenting with either clinical features of Rheumatoid arthritis described in modern medical literature or the clinical features of Amavata described in Madhava Nidana will be selected for sampling. Inclusion criteria involves 1. Patients having the clinical features of Amavata as described in Madhav Nidana  2. Patients fulfilling the 2010 ACR-EULAR criteria for Rheumatoid arthritis and so on. Exclusion Criteria involves Concomitant any other treatment (DMARDs, glucocorticoids etc) other than commonly prescribed Ayurvedic treatment of Amavata 2. Patients with crippling bone deformities 3. Seriously ill and moribund patients and so on. Adult subjects fulfilling the inclusion criteria and devoid of any of the exclusion criteria will be randomized as per simple randomization plan in two groups. GROUP-A (Trial group)- Pathya Counselling provided along with commonly prescribed Ayurvedic treatment of Amavata.

GROUP-B (Comparator group)- No Pathya Counselling provided along with commonly prescribed Ayurvedic treatment of Amavata..Assessment criteria involves Primary criteria is DAS-28 score. Secondary criteria is 1.Status of Dhatu Samyata and Vikaropshama (Charak Samhita) 2. Amavata symptom severity scale 3. Visual Analogue Scale (VAS) and Erythrocyte Sedimentation Rate (ESR). DAS-28 will be assessed on Day 1, 42 and 49. Status of Dhatu Samyata and Vikaropshama and Amavata symptom severity scale assessed on Day 1, 7,14, 21, 28, 35,42 and 49. VAS and ESR on Day 1, 42 and 49. Outcome Measures involves Primary outcome measure is Reduction in DAS-28 score. Secondary outcome measures are 1. Attainment of status of Dhatu Samayata and Vikaropsama. 2. Reduction in Amavata symptom severity scale. 3. Reduction in Visual Analogue Scale (VAS) and Erythrocyte Sedimentation Rate (ESR).  Level of improvement for outcome measures - DAS28 and ESR will be decided as poor, fair, good, very good and excellent relief. Reduction in Amavata symptom severity scale on the basis of five (5) item – four (4) point scale.  Attainment of Dhatu Samyata and Vikaropsama will be assessed on the basis of twelve (12) item-three (3) point scale. Patient’s data with three different levels of adherence to Pathya will be recorded as poor, good and excellent adherance depending on the number of violations of Pathya( wholesome and unwholesome diet and lifestyle regime) in a week.