| CTRI Number |
CTRI/2025/02/080829 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management Of Rheumatoid Arthritis With The Help Of Ayurvedic Medicine |
|
Scientific Title of Study
|
A randomized comparative study of ajmodadi churna and rasanadi churna in patients of amavata (rhuematoid 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 Mishrita Tala |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa J S Ayurveda Mahavidyalaya and P D Patel Ayurved Hospital college road nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9429041078 |
| Fax |
|
| Email |
mishritatala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Patel |
| Designation |
professor and HOD |
| Affiliation |
J.S.Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa J S Ayurveda Mahavidyalaya college road nadiad
Kheda
GUJARAT
India
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Patel |
| Designation |
professor and HOD |
| Affiliation |
J.S.Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa J S Ayurveda Mahavidyalaya college road nadiad
Kheda
GUJARAT
India
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| sundar ayurveda pharmacy, J S ayurveda mahavidyalaya, college road, district kheda,nadiad,
Gujarat,India 387001 |
|
|
Primary Sponsor
|
| Name |
J s ayurveda mahavidyalaya |
| Address |
college road
District kheda
nadiad
Gujarat
India
387001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Mishrita Tala |
P D Patel ayurveda hospital, nadiad |
Department of kayachikitsa opd room no.101 and room no.102, district kheda, nadiad , Gujarat 387001
Kheda
GUJARAT |
9429041078
mishritatala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ajmodadi curna, Reference: sarangdhar samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Usnodaka), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasanadi churna, Reference: yogratanakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 to 60 years of age of both the genders
Patient who fulfilling the diagnostic criteria signs and symptoms of amavata as well as confirmed diagnosis of rheumatoid arthritis
|
|
| ExclusionCriteria |
| Details |
Patients who have developed complications of rheumatoid arthritis such as severe deformity of joints bones pleura pericardial disease or else
Association of joint disease of other origin
Patients with any associated comorbidities
such as diabetes mellitus hypertension etc
Patients on prolonged medication with immunosuppressive such as corticosteroids any other drugs within last 6 months that may have influence on the outcome of the study
Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| is to evaluate the effect of compared ajmodadi churna to rasnadi churna in the patients of amavata and observing 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 |
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out the changes in DAS 28 scale and laboratory parameters like ESR and RA factor |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| Date of Study Completion (India) |
20/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This part provides both a concise summary of the entire thesis,
encapsulated in the abstract or brief description, and presents the conclusions
drawn from the observations and results.
|