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CTRI Number  CTRI/2024/04/065701 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of Amavata(Rheumatoid Arthritis) 
Scientific Title of Study   Multi-Dimensional Ayurvedic Management Of Amavata(Rheumatoid Arthritis) – A Single Arm, Pre-Post Designed Clinical Study 
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 Bhargavi N Acharya 
Designation  PG SCHOLAR 
Affiliation  J S Ayurveda Mahavidyalaya 
Address  Department of Kayachikitsa J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital college Road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9601727790  
Fax    
Email  acharyabhargavi97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Manish Patel 
Designation  Professsor and HOD 
Affiliation  J S Ayurveda Mahavidyalaya 
Address  Department of Kayachikitsa J S Ayurveda Mahavidyalaya and P D Patel Ayurveda hospital college road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9979589865  
Fax    
Email  manishayu97@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Manish Patel 
Designation  Professsor and HOD 
Affiliation  J S Ayurveda Mahavidyalaya 
Address  Department of Kayachikitsa J S Ayurveda Mahavidyalaya and P D Patel Ayurveda hospital college road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9979589865  
Fax    
Email  manishayu97@gmail.com  
 
Source of Monetary or Material Support  
sundar Ayurveda Pharmacy,J.S.Ayurveda Mahavidyalaya And P D Patel Ayurveda Hospital 
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya 
Address  J S Ayurveda mahavidyalaya,college road, nadiad 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
J S Ayurveda Mahavidyalaya  J S Ayurveda mahavidyalaya,college road, nadiad 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhargavi N Acharya  J S Ayurveda Mahavidyalaya and P D Patel ayurveda hospital  Department of Kayachikitsa J S Ayurveda Mahavidyalaya P D Patel ayurvedic hospital college road, nadiad-387001
Kheda
GUJARAT 		 9601727790

acharyabhargavi97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for human research MAM university  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
1Intervention ArmDrugClassical(1) Medicine Name: Simhanad Guggulu, Reference: Bhaishajyaratnvali amavatrogadhikara verse 181-184, Route: Oral, Dosage Form: Guggulu , Dose: 300(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: Dose 3 tab 3times (per day)
(2) Medicine Name: Yogaraja Guggulu, Reference: Rasatantrasara siddha prayoga sangraha dwittiya khanda page no-156, Route: Oral, Dosage Form: Guggulu , Dose: 300(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: Dose 3 tab 3times (per day)
(3) Medicine Name: Rasnapanchaka kwatha, Reference: sarangdhar samhita madhyama khanda, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information:
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: caraka samhita siddhi sthana , Procedure details: After virechana & sansarjana karma niruha basti (dasamoola kvatha 320ml) will be given for 13 days.Everyday baspaswedana and lepa will be done.jaloukavacharana will be done within two weeks.)
(1) Medicine Name: eranda sneha, Reference: bhavprakash samhita amavatrogadhikara verse 50, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: dashamoola kwatha, Reference: Bhaishajyaratnavali kasarogadhikara verse 13, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 13 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  patients will be diagnosed with amavata(rheumatoid arthritis) with the help of presence of signs and symptoms like sandhishula(pain in joints),sandhijadyata (stiffness in joints),sandhisotha(swelling in joints),restriction of movement.all the patients who diagnosed as an amavata will also be screened by parameters of 2010 acr-eular ra classification criteria for the diagnosis of rheumatoid arthritis.  
 
ExclusionCriteria 
Details  1)Patients who have developed complications of rheumatoid arthritis e.g., severe deformity of joints, bones, pleura-pericardial disease or else.
2)Association of joint disease of other origin.
3)Patients on prolonged medication with immunosuppressive e.g., corticosteroids, any other drugs within last 6 months that may have influence on the outcome of the study.
4)Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Find Out The Changes In Grade Score Of VAS Scale Of Joint Pain And Signs And Symptoms Of Amavata By Recording Them Before And After The Administration Of Treatment.  4 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
To Find out the Changes in DAS-28 Scale And Laboratory parameters like ESR And RA Factor  8 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/04/2024 
Date of Study Completion (India) 24/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 This will be submitted in form of Dissertation 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Amavata is a complex disease.The sign and symptoms of amavata(rheumatoid arthritis) are mostly resembled with rheumatoid arthritis of modern science. Rheumatoid arthritis is a chronic, inflammatory and autoimmune disease which affects joints and connective tissues.

A.   First phase: (1 to 14 days)

1.      Langhana: Only mudga bean soup or boiled mudga and boiled vegetables will be given twice a day as a diet. Hot water will be suggested for drink only. 

2.   Swedana: Every day sarvanga baspaswedana were given once in morning. Valuka swedana were given twice in a day.

3.  Dipana-Pachana: Fine powder of pippali churna were given in vardhamana krama. Dose of the pippali churna were given in increasing and decreasing pattern for 13 days.

4.   Lepana: Gugglu lepa applied on affected joints twice in a day.

5.   Virechana karma: Virechana was given after the baspaswedana. It is done with eranda sneha  Lunch was not be provided on the virechana day. After the proper virechana, mudga bean soup was given.  

A.   Second phase (15 to 28 days of treatment)

1.      Svedana and lepana were performed every day as like phase 1.

2.      Dipana-Pachana: Fine powder of pippali churna 1 gm were  given twice a day with warm water on empty stomach.

3.      Niruha basti (Dasamula kwatha: Basti were  given from 15th day of hospitalization every day before lunch for next 13 days. 

4.      Oral medicaments (shamana): (from 14th day to 28th day of treatment)

i          Simhanada guggulu: 3 tab (each tab 300 mg) 3 time with warm water after meal

ii        Yogaraja guggulu :3 tab (each tab 300 mg) 3 time with warm water after meal

iii      Rasnapancaka kvatha: 40 ml twice a day on empty stomach

5.      Jalaukavacarana (maximum 5 jalaukavacarana on affected and needful joints within two weeks period)

  

B.   Third phase (29 to 56 days of treatment)

Only oral medicines, mentioned above were given as an out-door level with prescribed diet and instructions.



 
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