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CTRI Number  CTRI/2023/02/049968 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   a comparative clinical study of erandbeejadi gutika pippalyadi gana kashaya and ruksha pottali sweda in the management of amavata 
Scientific Title of Study   a comparative clinical study to evaluate the efficacy of erandbeejadi gutika pippalyadi gana kashaya and ruksha pottali sweda in the management of amavata 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BYOMESH UPADHYAY 
Designation  PG Scholar Department of Kayachikitsa 
Affiliation  Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 
Address  OPD Number 2 and 18 , Department of kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  7566819731  
Fax    
Email  Upadhyaybyomesh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAruna Ojha 
Designation  Proffesor in Department of Kayachikitsa 
Affiliation  Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 
Address  opd no 2 and 18 Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRashmi Diwan 
Designation  Lecturer in Department of Kayachikitsa 
Affiliation  Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 
Address  Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9770933579  
Fax    
Email  rashmi.diwan3@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH  
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt. Ayurved College Raipur CHHATTISGARH 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH  
Type of Sponsor  Other [Government Ayurved College Raipur] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurved College Raipur CHHATTISGARH  Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 492010 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Byomesh Upadhyay  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH  opd no 2 and 18 ipd in the department of kayachikitsa at Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 492010
Raipur
CHHATTISGARH 
7566819731

Upadhyaybyomesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR (C.G.) 492010  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. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: pippalyadi gana kashaya, Reference: shushrut samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: erandbeejadi gutika, Reference: yogaratnakar amavata adhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: ushan jal), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  it is based on Clinical signs and symptoms mentioned in ayurvedic and modern classics, especially pain swelling, and stiffness.
Health Assessment Questionnaire for RA
Visual Analog Scale (VAS)
WOMAC Index
 
 
ExclusionCriteria 
Details 

1. Patients below 18 years and above 60 years of age will not be taken.
2. Patients who develop a secondary complication of RA e.g. pleuro-pericardial disease. severely damaged joint with bedridden patients and severe crippling deformities.
3. Patients having neoplasm of the spine, gout, ankylosing spondylitis, traumatic arthritis, and pyogenic osteomyelitis.
4. Patients suffering from paralysis, Liver cirrhosis, Liver failure, Hepatocellular or any carcinoma, and Ascites.
5. Patients having associated cardiac disease, pulmonary tuberculosis, uncontrolled diabetes mellitus, malignant hypertension, renal function impairment, etc.
6. Pregnant and lactating mother.
7. Patients who are taken steroids.
8. Other joint disorders like Gout, Osteoarthritis.
The patient mentioned above who is suffering from any severe disease will come under the category of exclusion.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduce the symptoms of amavata especially pain,swelling and stiffness(rheumatoid arthritis)  reduce the symptoms of amavata in 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improve the quality of life  90 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In the 7th century, acharya Madhava emphasizes that it is a systemic disorder involving digestive and metabolic mechanisms.in text described the main symptoms of Amavata clearly. They can be classified under the following headings: -Pratyatma Lakshana:- Sandhi Shoola, Sandhi Shotha, and Stabdhata.In modern science, It is correlated to rheumatoid arthritis (RA). It is a chronic autoimmune inflammatory systemic disease. In this, the body’s immune system attacks its tissue, which affects synovial joints with extra-articular manifestations. In this bilateral, peripheral joints are involved symmetrically.  Primary symptoms of RA are joint inflammation, pain, loss of function, and eventual joint destruction and deformity. For the present study, on amavata as shaman therapy, the medicine I choose is a suitable natural product that will make it possible for patients to live a high quality of life along with reducing the specific symptoms of pain, swelling & stiffness. These medicines have properties of deepan,pachan,shulahar & shothahar without any side effects in our textes. Considering the magnitude of amavata, I am doing a clinical & comparative study of Erandbeejadi Gutika, Pippalayadi Gana Kashaya & Ruksha pottali Sweda in the management of Amavata.

the volunteers will be informed about the study protocol. willing participants will be randomly selected as per the coin method.  clinical research format will be prepared and validated before the study approval will be taken from the IEC of the NPA government Ayurved college and hospital, Raipur C.G.and CTRI registration will be done. after selection, each participant will be tasted individually and selected according to the selection criteria.

Sixty patients of Amavata will be selected from Kayachikitsa OPD and IPD Shrihri NPA government Ayurved college and hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socio‑economic conditions. Both acute and chronic phases of Amavata patients were taken for the study, following the ACR criteria for diagnosing RA in modern medicine and the clinical features of Amavata described in Madhava Nidana. The present study is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60 clinically diagnosed and registered patients of Amavata were divided randomly by coin method into two groups. Each group will have 30 patients. Group A: 30 clinically diagnosed patients of Amavata will be treated with erandbeejadi gutika two tablets(each 500 mg) four times in a day with lukewarm water before meal for 90 days along with modified ruksha sweda.Group B: 30 clinically diagnosed patients of Amavata were treated with pippalyadi gana kashaya 50 ml two times n a day as patient Agni Bala aftAgni Balafor 90 days along with  modified ruksha sweda.modified ruksha pottali sweda :-Ingredient:- Baluka (50%) +Shunthi+Yava+Saindhav Lavan+Methi+Shatpushpa (50%).

 

 
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