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CTRI Number  CTRI/2023/04/051366 [Registered on: 06/04/2023] Trial Registered Prospectively
Last Modified On: 30/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Whole system ayurvedic approch for the management Of amavata 
Scientific Title of Study   Whole system ayurvedic approach for the management of amavata (rheumatoid arthritis) -a pre-post designed single group clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya N Patel 
Designation  P G Scholar 
Affiliation  j s ayurveda mahavidhyalaya 
Address  Department of kayachikitsa j s ayurveda mahavidhyalaya collage road nadiad kheda gujarat 387001 india

Kheda
GUJARAT
387001
India 
Phone  9429142891  
Fax    
Email  priya262231@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Dhaval Dholakiya 
Designation  Professor 
Affiliation  j s ayurveda mahavidhyalaya 
Address  Department of kayachikitsa j s ayurveda mahavidhyalaya collage road nadiad kheda gujarat 387001 india

Kheda
GUJARAT
387001
India 
Phone  7016786089  
Fax    
Email  vddhavaldholakiya1910@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priya N Patel  
Designation  P G Scholar 
Affiliation  j s ayurveda mahavidhyalaya 
Address  Department of kayachikitsa j s ayurveda mahavidhyalaya collage road nadiad kheda gujarat 387001 india

Kheda
GUJARAT
387001
India 
Phone  9429142891  
Fax    
Email  priya262231@gmail.com  
 
Source of Monetary or Material Support  
SUNDAR AYURVEDA TEACHING PHARMACY OF J S AYURVEDA MAHAVIDHYALAYA NADIAD 
 
Primary Sponsor  
Name  J S AYURVEDA MAHAVIDHYALAYA 
Address  J S AYURVEDA MAHAVIDHYALAYA COLLAGE ROAD NADIAD 
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 Priya N Patel   P d patel ayurveda hospital  Department of kayachikitsa j s ayurveda mahavidhyalaya collage road nadiad kheda gujarat 387001 india
Kheda
GUJARAT 		 9429142891

priya262231@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE FOR HUMAN RESEARCH  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: PIPPALI CURNA, Reference: CARAKA SAMHITA SADVIRECANASATASTRITIYA,VERSE 9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: ADMINISTERED IN VARDHAMANA KRAMA
(2) Medicine Name: YOGARAJA GUGGULU, Reference: BHAISAJYA RATNAVALI,AMAVATADHIKARA,VERSE 90-95, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: DOSE:3 TAB-3 TIMES (PER DAY)
(3) Medicine Name: SIMHANADA GUGGULU, Reference: BHAISAJYA RATNAVALI,AMAVATADHIKARA,VERSE 130-135, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: DOSE:3 TAB-3 TIMES (PER DAY)
(4) Medicine Name: SIMHANADA GUGGULU, Reference: BHAISAJYA RATNAVALI,AMAVATADHIKARA,VERSE 130-135, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: DOSE:3 TAB-3 TIMES (PER DAY)
2Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: , Procedure details: EVERY DAY SARVANGA BASPASVEDANA WITH THE HELP OF STEAM GENERAYED FROM NIRGUNDI LEAVES DECOCTION WILL BE GIVEN ONCE IN MORNING.VALUKA SVEDANA WLL BE GIVEN TWICE IN A DAY.)
3Intervention ArmProcedure-lepa, लेप (Procedure Reference: , Procedure details: GUGGULU LEPA APPLIED ON AFFECTED JOINTS TWICE IN A DAY)
4Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: CARAKA SAMHITA KALPASTHANA, Procedure details: VIRECANA WILL BE BE GIVEN AFTER THE BASPASVEDANA.IT IS DONE WITH ERANDA SNEHA (DOSE WILL BE VARIED FROM 30 ML TO 60 ML ACCORDING TO THE KOSTHA).LUNCH WILL NOT BE PROVIDED ON THE VIRECANA DAY.AFTER THE PROPER VIRECANA,MUDGA BEAN SOUP WILL BE GIVEN.NEXT DAY WILL BE THE REST DAY AND MUDGA WILL BE GIVEN ON THIS DAY.VALUKA SVEDANA OR LEPANA MAY GIVE TO THE PATIENT IF REQUIRE)
(1) Medicine Name: ERANDA SNEHA, Reference: BHAVPRAKASH MADHYAMA KHANDA,AMAVATA ROGADHIKARA,VERSE 50, Route: Oral, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 1 Days
5Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: CARAKA SAMHITA SIDDHI STHANA , Procedure details: THE PROCEDURE IN WHICH THE MEDICINES ARE INTRODUCED INSIDE THE BODY THROUGH THE RECTUM.)
(1) Medicine Name: DASMULA KVATHA, Reference: BHAISAJYA RATNAVALI,KASAROGADHIKARA,VERSE13, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 14 Days
6Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: , Procedure details: MAXIMUM 5 JALAUKAVACARANAON AFFECTED AND NEEDFUL JOINTS WITHIN TWO WEEKS PERIOD.)
7Intervention ArmProcedure-agnikarma अग्निकर्म (विषोपक्रमः) (Procedure Reference: , Procedure details: DONE ON WHEN PAIN WILL AGGRAVATE)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 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),sandhishoth(swelling in joints),restriction of movement.all the patients who diagnosed as an amavata wll 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 
Not applicable  Not applicable 
 
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   N/A 
Date of First Enrollment (India)   01/05/2023 
Date of Study Completion (India) Date Missing 
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 is published as a dissertation. 
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [priya262231@gmail.com].

  6. For how long will this data be available start date provided 01-05-2023 and end date provided 01-11-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NO
Brief Summary
Modification(s)  

Whole system ayurvedic approach for the management of Amavata (Rheumatoid Arthritis) A pre-post designed single group clinical study is the main object of the study. This clinical study was performed at P. D. Patel Ayurveda Hospital, Nadiad. Total 20 patients were registered and all of them are completed the treatment. All the patients were treated with following therapy. Patients were assessed by grade score symptomatically before and after completion of treatment. The study result was statistically analyzed by using paired t test. A value of p<0.001 was considered as statistically significant.

Treatment Protocol Overview

A. First Phase (Days 1-14) 

1. Langhana: Diet restricted to munga bean soup or boiled munga and vegetables, served twice daily; hot water only.

2. Svedana: Daily steam therapy using nirgundi leaves in the morning and valuka svedana twice daily.

3. Dipana-Pacana: Gradual dosing of pippali curna for digestion over 13 days.

4. Lepana: Gugglu lepa applied to affected joints twice daily.

5. Virecana Karma: Administered after svedana using eranda sneha (30-60 ml based on digestion). No lunch on virecana day; follow with munga soup and a rest day.

B. Second Phase (Days 15-28)

1. Svedana and Lepana: Continued daily.

2. Dipana-Pacana: Pippali curna (1 gm) twice daily on an empty stomach.

3. Niruha Basti: Administered daily before lunch for 13 days.

4. Oral Medicaments: 

- Simhanada Guggulu: 3 tabs (300 mg) three times daily post-meal.

- Yogaraja Guggulu: Same dosage.

- Rasnapacaka Kvatha: 40 ml twice daily on an empty stomach.

5. Jalaukavacarana: Up to 5 leech therapies on affected joints over two weeks.

6. Agni Karma: Administered when pain increases.

7. Adjustments: Investigator may modify treatments based on patient complaints. NSAIDs or other medications should be stopped 5 days prior.

C. Third Phase (Days 29-56)

- Focus on Samana Treatment: Continue prescribed oral medications and follow dietary instructions as an outpatient.This structured approach aims to manage joint pain effectively through a combination of dietary modifications, herbal therapies, and specific treatments.


 
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