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CTRI Number  CTRI/2024/07/069764 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effect of Panchmooladi churna in Amavata 
Scientific Title of Study   “APPLIED STUDY OF “Prameha vata medoghni tu amavate prayojyate” W. S. R TO RHEUMATOID ARTHRITIS”. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Puspa Priyadarshani 
Designation  P.G Scholar 
Affiliation  Goverment Ayurvedic College and Hospital Patna 
Address  Depatrment of Samhita evum Siddhant Goverment Ayurvedic College and Hospital patna

Patna
BIHAR
800003
India 
Phone  8328892247  
Fax    
Email  kdhoney96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prof Vijay Shankar Pandey 
Designation  Professor 
Affiliation  Goverment Ayurvedic College and Hospital Patna 
Address  Depatrment of Samhita evum Siddhant Goverment Ayurvedic College and Hospital patna

Patna
BIHAR
800003
India 
Phone  9334124587  
Fax    
Email  vijmrs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prof Vijay Shankar Pandey 
Designation  Professor 
Affiliation  Goverment Ayurvedic College and Hospital Patna 
Address  Depatrment of Samhita evum Siddhant Goverment Ayurvedic College and Hospital patna

Patna
BIHAR
800003
India 
Phone  9334124587  
Fax    
Email  vijmrs@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University patna 
 
Primary Sponsor  
Name  Goverment Ayurvedic College and Hospital Patna Aryabhatta Knowledge University patna Bihar 
Address  Department of Samhita evum Sidhhant Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University patna Bihar 800003  
Type of Sponsor  Research institution and hospital 
 
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 Puspa Priyadarshani  Government Ayurvedic College and Hospital patna Bihar  Department of Samhita evum Siddhant OPD room no- 10 patna bihar
Patna
BIHAR 		 8328892247

kdhoney96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVA, (2) ICD-10 Condition:M256||Stiffness of joint, not elsewhereclassified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: panchmooladi choorna, Reference: charak samhita chikitsha sthana, grahanidosha chikitsa adhyaya 15/88-93, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. age 20 -60 years
2. having sign and symptoms as per Ayurveda and modern
3. willing for trial and co operative  
 
ExclusionCriteria 
Details  1. age more than 60 years
2. chronicity more than 10 years
3. 50% joints are involved
4. having any other serious underlying diseases 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
outcome will be measured by
1. healthy movement of joints
2. no difficulty in walking or doing day work
3. reduced inflammation of joints
4. Normal range of ESR, CRP, CBC, RF 		 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. proper functioning of joints
2. proper digestion of food , i.e. no formation of Ama
3. reduced swelling and inflammation
4. proper mobility 		 60 days  
 
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 2 
Date of First Enrollment (India)   10/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kdhoney96@gmail.com].

  6. For how long will this data be available start date provided 07-01-2024 and end date provided 24-04-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Rheumatoid Arthritis (RA) is the most common persistent inflammatory arthritis of unknown etiology characterized by morning stiffness, swelling of joints, restricted movement of joints, pain etc. in ayurveda RA  is co-related with Amavata. amavata is said to be originated due to formation of Ama (partial digestion of food particles), Ama with vata dosha said to cause the disease Amavata. having the sign and symptoms resembling to that of RA. the drug used in this trial is Panchmooladi churna mentioned in Ayurvedic text which is used to treat Ama formation in body with the hope that it will prove more efficacious, less toxic and easy to use. the drug is easily available and effective in reducing ama formation. duration of treatment 60 days , patients will be taken from OPD and IPD of Government Ayurvedic college and hospital patna. 
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