| CTRI Number |
CTRI/2025/12/098985 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of two polyherbal Unani formulations on blood-based biomarkers in Rheumatoid
Arthritis patients |
|
Scientific Title of Study
|
Effect of two polyherbal Unani formulations used for Waja al Mufasil (Rheumatoid Arthritis/L-4) on serum biomarkers, inflammasomes activation, pyroptosis and endothelial dysfunction - A clinical and in-vitro study to understand their mechanism of action |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Towseef Amin Rafeeqi |
| Designation |
Dr Towseef Amin Rafeeqi |
| Affiliation |
CCRUM-Regional Research Institute of Unani Medicine Srinagar |
| Address |
Biochemistry Lab Room No 111 Clinical Research Unit RRIUM Srinagar Under CCRUM
Ministry of AYUSH GoI Univ of Kashmir Naseembagh Campus
Srinagar J&K
Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9149998380 |
| Fax |
|
| Email |
towseef1.ccrum@ccrum.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Huma Habib |
| Designation |
Research Officer |
| Affiliation |
CCRUM-Regional Research Institute of Unani Medicine Srinagar |
| Address |
Clinical Research Unit Room no 158 RRIUM Srinagar University of Kashmir Campus Srinagar
J&K Under CCRUM Ministry of AYUSH GoI
Srinagar
JAMMU & KASHMIR
190006
India
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9796550059 |
| Fax |
|
| Email |
humma.ccrum@ccrum.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arsheed Iqbal |
| Designation |
Research Officer |
| Affiliation |
CCRUM-Regional Research Institute of Unani Medicine Srinagar |
| Address |
Clinical Research Unit Room no 04 RRIUM Srinagar University of Kashmir Campus Srinagar
J&K Under CCRUM Ministry of AYUSH GoI
Srinagar
JAMMU & KASHMIR
190006
India
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006019911 |
| Fax |
|
| Email |
drarsheediqbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCRUM Ministry of Ayush GoI |
|
|
Primary Sponsor
|
| Name |
Central Council of Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No 61-65 Industrial area opp D Block Janakpuri New Delhi 110058 India |
| Type of Sponsor |
Research 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 Huma |
Regional Research Institutie of Unani Medicine (RRIUM) Srinagar |
Clinical Research Unit, Room No. 158 Regional Research Institute of Unani Medicine (RRIUM) Srinagar University of Kashmir Campus Hazratbal Srinagar
Srinagar
JAMMU & KASHMIR |
9796550059
humaccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Regional research institute of Unani Medicine Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants will be taken as controls for biomarker analysis |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methotrexate |
Tablet form will be given 7.5 mg per week for 8 weeks |
| Intervention |
Nushkha for Ghatiya |
The Unani formulation will be given in powder form 7 gm per day for 8 weeks |
| Intervention |
UNIM 301 |
The Unani formulation will be given in 500 gm capsule as 2 capsules three times a day for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex in the age group 18-65 years.
ACR-EULAR criteria with moderate disease activity only.
1). Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint.
2). Absence of an alternative diagnosis for the observed synovitis (arthritis).
3). A total score of atleast 6 from the individual scores in 4 domains:
a). Number and site of involved joints (range 0-5)
b). Serological abnormalities (range 0-3)
c). Elevated acute-phase reactants (range 0-1)
d). Duration of symptoms (range 0-3)
|
|
| ExclusionCriteria |
| Details |
Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g., Joint subluxation and collapse).
Obese patients BMI 30.
History or clinical evidence of any systemic inflammatory condition other than RA,
such as juvenile chronic arthritis, spondyloarthropathy, IBD, psoriatic arthritis, active
vasculitis, or gout that may interfere with evaluation.
History or clinical evidence of any serious systemic illness, DM, TB, HIV infection, etc
Are currently receiving or have received intra-articular treatment (e.g., corticosteroids
or hyaluronic acid), oral or parenteral corticosteroids, or NSAIDs within 2 weeks of
study entry and DMARDs or IFN therapy within 4 weeks before study entry or are
anticipated to require IFN therapy during the study.
Screening laboratory test values, including S. Creatinine, BUN, S. Bilirubin outside the
reference range, and SGOT, SGPT raised 2.5 times the ULN.
History of hypersensitivity to the study drug or any of its ingredients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome was the change from baseline to week 8 in the signs and symptoms of rheumatoid arthritis based on the Disease Activity Score (DAS) after treatment. Secondary outcomes included the change in the biomarker levels at 8 weeks of treatment. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in serum biomarker levels after Unani
intervention and in comparison to healthy participants |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 present study will help to establish the possible mechanism of action of the herbal Unani formulations. This type of study will help to understand the molecular mechanism of these unani formulations used for wajalmufasil (rhematoid arthritis). this type of study will provide scientific validation and will help to create evidence-based recommendations for these unani formulations. This type of study will be the essential prerequisite for a larger sample size mechanistic study. Moreover, this type of study will help guide the clinical and therapeutic management of RA and ultimately benefit the broader population. |