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CTRI Number  CTRI/2019/01/017359 [Registered on: 31/01/2019] Trial Registered Prospectively
Last Modified On: 31/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Check the Comparative Effectiveness of "Wholesome and Unwholesome Diet and Lifestyle counselling" in management of "Rheumatoid Arthritis"  
Scientific Title of Study   A Comparative Study to Evaluate Effectiveness of "Pathya Counselling"in Management of "Amavata (Rheumatoid Arthritis)" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Kumar Pandey  
Designation  Associate Professor (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 110073
Khera Dabar New Delhi 110073
New Delhi
DELHI
110073
India 
Phone  9013858523  
Fax    
Email  dryogeshpandey@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aakanksha Arora 
Designation  MD Scholar (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 110073
Khera Dabar New Delhi 110073
New Delhi
DELHI
110073
India 
Phone  8860796456  
Fax    
Email  aakankshaarora_55@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh Kumar Pandey 
Designation  Associate Professor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 110073
Khera Dabar New Delhi 110073
New Delhi
DELHI
110073
India 
Phone  9013858523  
Fax    
Email  dryogeshpandey@gmail.com  
 
Source of Monetary or Material Support  
OPD and IPD of Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 110073 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogesh Kumar Pandey  Chaudhary Brahm Prakash Ayurved Charak Sansthan  Dept of Kayachikitsa
New Delhi
DELHI 		 9013858523

dryogeshpandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Commonly Prescribed Ayurvedic treatment in Amavata   Commonly Prescribed Ayurvedic Treatment in Amavata for a duration of 7 weeks(49 days) which is as under Rasna erandadi Kwath 40ml BD before meals Agnitundi Vati 1Tab 125mg TDS with luke warm water after meals Ajmodadi Churna 3g BD with luke warm water before meals Baluka Sweda for 20 min daily 
Intervention  Pathya Counselling Advised along with Commonly Prescribed Ayurvedic treatment in Amavata  Wholesome and Unwholesome Diet and Lifestyle Counselling advised along with Commonly Prescribed Ayurvedic Treatment in Amavata for a duration of 7 weeks(49 days) which is as under Rasna erandadi Kwath 40ml BD before meals Agnitundi Vati 1 Tab 125mg TDS with luke warm water after meals Ajmodadi Churna 3g BD with luke warm water before meals Baluka Sweda for 20 min daily 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having the clinical features of Amavata as described in Madhav Nidana
Patients fulfilling the 2010 ACR-EULAR criteria for Rheumatoid arthritis
Patients who are only on commonly prescribed Ayurvedic treatment of Amavata
Patients not following any dietary restrictions from past 6 months
Age 21 to 60 years
Sex both sexes
Patients suffering from disease for less than 3yrs
Patients who are ready to give consent for trial
Patients with firm home address and contact no which is readily accessible during course of trial 
 
ExclusionCriteria 
Details  Concomitant any other treatment (DMARDs glucocorticoids etc) other than commonly prescribed Ayurvedic treatment of Amavata Patients with crippling bone deformities Seriously ill and moribund patients
Abnormal renal or hepatic functions malignancy hypertension cardiovascular disorder HIV-AIDS etc
Patients planning to conceive in near future (during course of trial)
Pregnant and lactating mothers
Any major psychiatric illness
Any other pre-existing illness that will require surgery during course of trial
Patients with any other concomitant Arthropathy like Ankylosing Spondylosis Osteomyelitis Gouty Arthritis Neoplasm of spine Fractures etc  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in DAS-28 score   Day1 Day42 Day49 
 
Secondary Outcome  
Outcome  TimePoints 
Attainment of status of Dhatu Samayata and Vikaropsama
Reduction in Amavata symptom severity scale


 		 Day1 Day7 Day14 Day21 Day28 Day35 Day42 Day49 
Reduction in Visual Analogue Scale (VAS) and Erythrocyte Sedimentation Rate (ESR)  Day1 Day42 Day49 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not available 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   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 “srotas”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)”. 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.
 
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