| CTRI Number |
CTRI/2025/12/098494 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effectiveness of Rhukot Forte Tablet in Improving Clinical Outcomes in Individuals with Rheumatoid Arthritis |
|
Scientific Title of Study
|
Effectiveness of Rhukot forte Tablet in Rheumatoid Arthritis - A QuasiExperimental 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 Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Department of Clinical Research and marketing Vaidyaratnam P S Variers Aryavaidysala Kottakkal Malappuram
India
Malappuram
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Department of Clinical Research and marketing Vaidyaratnam P S Variers Aryavaidysala Kottakkal Malappuram
India
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Department of Clinical Research and marketing Vaidyaratnam P S Variers Aryavaidysala Kottakkal Malappuram
India
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P.S Varier Aryavaidyasala Kottakkal P.O Malappuram Kerala 676503 |
|
|
Primary Sponsor
|
| Name |
The managing trustee |
| Address |
Vaidyaratnam P S Varier Aryavaidyasala Kottakkal Malappuram 676503 |
| Type of Sponsor |
Other [Charitable institution] |
|
|
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 Anoop AK |
Arya Vaidya Sala Hospital , Kottakkal |
Special OPD
Malappuram
KERALA |
04832806520
researchmarketing@aryavaidyasala.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Aryavaidyasala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Rhukot forte, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants with Joint pain & stiffness satisfying the ACR classification criteria for Rheumatoid Arthritis |
|
| ExclusionCriteria |
| Details |
1. Known systemic inflammatory conditions other than RA and participants with ANA positive are also excluded
2. Known case of Malignancy
3. Known Cardiovascular disorders (such as Coronary artery disease, Rheumatic heart disease, congenital heart disease and Cardiac myopathy)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Noticing improvements in joint pain, swelling, and tenderness can be a significant relief
|
14DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved blood parameters: reduced ESR, CRP, RA Factor, and Serum Uric Acid |
14 DAYS |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
22/01/2026 |
| 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 Applicable |
| 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
|
The study titled Effectiveness of Rhukot Forte Tablet in Rheumatoid Arthritis – A Quasi Experimental Study aims to evaluate the therapeutic potential of Rhukot Forte a polyherbal Ayurvedic formulation, in managing Rheumatoid Arthritis (RA). The quasi-experimental trial will include 34 participants (aged 20–40 years) with RA recruited from the OPD of Arya Vaidya Sala Kottakkal. Each participant will receive 2 tablets thrice daily for 14 days followed by a one-week follow-up. Effectiveness will be assessed using DAS-28 score and RAID questionnaire along with laboratory parameters (ESR, CRP, RA factor) The study adopts a structured methodology with ethical safeguards including informed consent and withdrawal provisions. Statistical analysis will be performed using SPSS, applying appropriate parametric and non-parametric tests |