| CTRI Number |
CTRI/2026/01/100245 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Unani formulation UNIM-301 in Rheumatoid arthritis |
|
Scientific Title of Study
|
Evaluating the Efficacy and Safety of the Oral Polyherbal Drug Unani UNIM 301
as an Add On Therapy to Standard Care in Rheumatoid Arthritis A
Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tamanna Nazli |
| Designation |
Research Officer |
| Affiliation |
CCRUM, MINISTRY OF AYUSH |
| Address |
335, Unani Medical Centre, 3rd floor, ABVIMS and Dr RML Hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
01123404594 |
| Fax |
|
| Email |
tamanna.ccrum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abdul Raheem |
| Designation |
Research Officer, Head Of the Department |
| Affiliation |
CCRUM, MINISTRY OF AYUSH |
| Address |
335, Unani Medical Centre, 3rd floor, ABVIMS and Dr RML Hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9810919345 |
| Fax |
|
| Email |
drabdulraheemccrum@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abdul Raheem |
| Designation |
Research Officer, Head Of the Department |
| Affiliation |
CCRUM, MINISTRY OF AYUSH |
| Address |
335, Unani Medical Centre, 3rd floor, ABVIMS and Dr RML Hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9810919345 |
| Fax |
|
| Email |
drabdulraheemccrum@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML Hospital, New Delhi-110001, India |
|
|
Primary Sponsor
|
| Name |
CENTRAL COUNCIL FOR RESEARCH IN UNANI MEDICINE |
| Address |
61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Tamanna Nazli |
Department of Rheumatology |
ABVIMS & Dr RML Hospital
New Delhi 110001
Central
DELHI |
9810981371
tamanna.ccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF ABVIMS & DR RML HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Traditional disease-modifying antirheumatic drugs DMARDs |
methotrexate, & or sulfasalazine, & or hydroxychloroquine along with non pharmacological interventions such as patient education, exercise, physical therapy, joint protection techniques and lifestyle changes |
| Intervention |
UNIM301 |
UNIM301 is a Unani coded polyherbal formulation, 2 tablets of UNIM-301 containing 500mg of active ingredients, orally thrice daily an hour after meals along with non-pharmacological interventions such as patient education, exercise, physical therapy, joint protection techniques and lifestyle changes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Trial Participants of either sex, aged 18-65 years
2. Trial Participants with definite rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria.
3. Disease duration less than 5 years since persistent arthritis
4. Trial Participants having at least one swollen or tender joint
5. Trial Participants with DAS28 score more than 3.2 %
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and nursing patients
2. Trial Participants with severe anemia Hb level less than 13 g per dL in men; less than 12 g per dL in women
3. Trial Participants on corticosteroid therapy in the past 3 month
4. Trial Participants on biological therapy
5. Trial Participants resistant to treatment with more than three traditional DMARD’s
6. Trial Participants those in remission or with low disease activity
7. Significant cardiac, pulmonary & hepato renal dysfunction
8. Known cases of Hepatitis B, Hepatitis C, HIV or malignancies
9. Trial Participants unsure about attending treatment schedule regularly
10. Trial Participants having Gout, or complicated RA
11. Abnormality at baseline investigation in SGOP, SGPT, ALP , S. Creatinine, B, Urea if raided more than 2.5 times the normal value
12. Trial Participants having GFR significantly lower than 60 mL per min.
13. Severe cases of RA Stage III & IV
14. Diagnosed cases of Ankylosing spondylosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Measures of disease severity
o ACR-EULAR
o DAS28CRP and DAS28ESR
o Simlified Disease Activity Index
2. Mental health Quality of Life assessment
o The Health Assessment Questionnaire Disability Index
3. Laboratory Measures
o To confirm diagnosis & track response – Rheumatoid Factor and Anti-Citrullinated Protein Antibody i.e.Anti–cyclic Citrullinated Peptide Antibodies
o Inflammatory markers – ESR, CRP
o To assess joint damage progression X-ray of affected joint
4. Safety and Adverse Event Monitoring
o CBC
o LFT
o KFT
|
1. Measures of disease severity
o ACR-EULAR at screening, 0,4,8,12,16,28 week
o DAS28CRP and DAS28ESR at screening, 0,4,8,12,16, 20,24,28 week
o Simlified Disease Activity Index at 0,4,8,12,16, 20,24,28 week
2. Mental health Quality of Life assessment at 0,4,8,12,16, 20,24,28 week
o The Health Assessment Questionnaire Disability Index at 0,4,8,12,16, 20,24,28 week
3. Laboratory Measures
o To confirm diagnosis & track response – Rheumatoid Factor and Anti-Citrullinated Protein Antibody i.e.Anti–cyclic Citrullinated Peptide Antibodies 0, 16, 28 week
o Inflammatory markers – ESR, CRP screening, 0,4,8,12,16, 20,24,28 week
o To assess joint damage progression X-ray of affected joint at 0, 24 week
4. Safety and Adverse Event Monitoring at 0,4,8,12,16, 28 week
o CBC
o LFT
o KFT
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="244"
Sample Size from India="244"
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)
|
15/01/2026 |
| 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="3"
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
|
This clinical study aims to evaluate the effectiveness and safety of the oral polyherbal Unani formulation UNIM 301 as an add on therapy to standard DMARD treatment in patients with mild to moderate rheumatoid arthritis. Participants will be assigned either to unani group having UNIM 301 plus Standard of Care DMARDs or control group of Standard of Care alone. The study focuses on achieving remission or low disease activity, and preventing radiographic progression. The primary objectives are to compare the efficacy, safety, and relapse rates between the two treatment groups. The secondary objectives include evaluating the rapidity of clinical response and improvement in quality of life. All participants will receive treatment for 16 weeks, followed by a 12 week post treatment follow up. |