| CTRI Number |
CTRI/2025/04/084811 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rheumatoid arthritis intervention of Ayurveda medicine for the period of 60 days. Outcome will be improvement in DAS 28 score along with relief the symptoms |
|
Scientific Title of Study
|
Effect of Ayurveda Management protocol on Rheumatoidarthritis-ARandomized Control Clinical Trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti Ramesh Tarapure |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
SGR Ayurved Mahavidyalaya, Associated with Seth sakharam nemchand Ayurved rugnalaya, Department of Kayachikitsa(General Medicine)
Room no-02
Solapur
MAHARASHTRA
413002
India |
| Phone |
09482126538 |
| Fax |
|
| Email |
shruti.tarapure@sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Basavraj Tubaki |
| Designation |
HOD & Professor |
| Affiliation |
|
| Address |
KLE’BMK Ayurveda Mahavidyala attached Hospital shahapur,Belagavi.Kayachikitsa OPD No-10
KLE’BMK Ayurveda Mahavidyala attached Hospital shahapur,Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Ramesh Tarapure |
| Designation |
Assistant Professor |
| Affiliation |
SGR Ayurved Mahavidyalaya, Solapur |
| Address |
Department of Kayachikitsa(General Medicine)
SGR Ayurved Mahavidyalaya, Solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
09482126538 |
| Fax |
|
| Email |
shruti.tarapure@sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| SGR Ayurved Mahavidyalaya, Budhawar Peth, Solapur, Maharashtra 413003. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [No sponsor study] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shruti Ramesh Tarapure |
SGR Ayurved Mahavidyalaya, Associated with Seth Sakharam Nemchand Ayurved Rughnalaya,Solapur |
Kyachikitsa department OPD, Room no 2, Sukharawar Peth, Samrat Chowk, Solapur 413003
Solapur
MAHARASHTRA |
09482126538
shruti.tarapure@sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M048||Other autoinflammatory syndromes. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab. Methotrexate | | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Simhanada Guggulu, Reference: Bhaishajya Ratnavalli, Route: Oral, Dosage Form: Guggulu , Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Vaishwanar Churna , Reference: Chakradatta , Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information: -(3) Medicine Name: Rasonadi Kashaya, Reference: Bhavprakash 29/21, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information: -(4) Medicine Name: Vaitarana Basti, Reference: Chakradatta 73/32, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 400(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: -(5) Medicine Name: Anuvasana Basti, Reference: Chakradatta , Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Dignosed as per ACR Criteria
Either Sex
Age group 20-60 years
Patient fit for basti procedure |
|
| ExclusionCriteria |
| Details |
1. Chronicity of more than 10 years
2. Having severe crippling deformity
3. Patients with uncontrolled systemic illness like hypertension and diabtes, cardiac illness etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DAS 28 Score, ACR |
at every follow up 9,14,28,45,60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DAS 28, ACR Criteria, RA titer, IL6 |
0th & 60th day(RA titer, IL6)
0th,9th,15th,30,45,60th day( DAS 28, ACR Criteria) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/05/2025 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Assessment of individual therapeutic responses provides valuable information concerning treatment benefits in individual
patients. We evaluated individual therapeutic responses as determined by the Disease Activity Score-28 joints critical differ
ence for improvement (DAS28-dcrit) in rheumatoid arthritis (RA) patients treated with intravenous tocilizumab or comparator
anti-tumor necrosis factor (TNF) agents. The previously published DAS28-dcrit value [DAS28 decrease (improvement) ≥ 1.8]
was retrospectively applied to data from two studies of tocilizumab in RA, the 52-week ACT-iON observational study and
the 24-week ADACTA randomized study. Data were compared within (not between) studies. DAS28 was calculated with
erythrocyte sedimentation rate as the inflammatory marker. Stability of DAS28-dcrit responses and European League Against
Rheumatism (EULAR) good responses was determined by evaluating repeated responses at subsequent timepoints. |