| CTRI Number |
CTRI/2025/09/094018 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of Metformin (1000 mg/d) in addition to Standard of Care (SOC) in
Management of Rheumatoid Arthritis: |
|
Scientific Title of Study
|
Efficacy and Safety of Metformin (1000 mg/d) as Adjuvant to Standard of Care (SOC) in
Management of Rheumatoid Arthritis: A Prospective, Randomized, Comparative Study (Version
1.0, dt. 01/07/2025) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DYP/IECBH/2025/188 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Sachin Kale |
| Designation |
Professor |
| Affiliation |
DY Patil deemed to be University School of Medicine, Navi Mumbai |
| Address |
Orthopaedics department 3rd floor, OPD no. 22 DY Patil hospital , Navi Mumbai 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9821431687 |
| Fax |
|
| Email |
sachin.kale@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adwait Malik |
| Designation |
Junior Resident 1 |
| Affiliation |
DY Patil deemed to be University School of Medicine, Navi Mumbai |
| Address |
Dept. of Pharmacology, 5th floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai - 400 706
Thane
MAHARASHTRA
400706
India |
| Phone |
9082895271 |
| Fax |
|
| Email |
adwait.malik.01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adwait Malik |
| Designation |
Junior Resident 1 |
| Affiliation |
DY Patil deemed to be University School of Medicine, Navi Mumbai |
| Address |
Dept. of Pharmacology, 5th floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai - 400 706
Thane
MAHARASHTRA
400706
India |
| Phone |
9082895271 |
| Fax |
|
| Email |
adwait.malik.01@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y. PATIL HOSPITAL,Plot-2, Sector-5, Nerul, Navi Mumbai,400706, INDIA |
|
|
Primary Sponsor
|
| Name |
D. Y. Patil Deemed to be University School of Medicine, Navi-Mumbai |
| Address |
Dept. of Pharmacology, 5th floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai - 400 706 |
| Type of Sponsor |
Private medical college |
|
|
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 Sachin Kale |
D.Y. Patil Hospital, Nerul, Navi Mumbai. |
Orthopaedics department 3 rd floor , OPD no. 22 D.Y. Patil Hospital, Nerul, Navi Mumbai.
Thane
MAHARASHTRA |
9821431687
sachin.kale@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health Research (IECBH) of Dr D Y Patil Medical College & Hospital, Navi Mumbai |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PLacebo |
Placebo tablet (Calcium 500mg) |
| Intervention |
Tab. Metformin 500 mg |
TAblet MEtformin 500 mg BD orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to ACR or EULAR 2010 criteria.
2. Patients received the standard therapy (i.e., one or more conventional DMARDs) for at least three months
3. Diagnosed cases of Rheumatoid arthritis (Rheumatoid Arthritis factor positive).
4. Onset of symptom duration greater than or equal to 6 months at the time of screening
5. Greater than or equal to 5 score on 10-point visual analogue scale (VAS) for pain at baseline.
6. Willing to give consent for participating in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients having severe disabling arthritis in the targeted or contralateral joint.
2. Patients with radiologically abnormal knee alignment.
3. Patients with a history of Chikungunya, Dengue, or other viral infections in the past six months.
4. Participants with a history or presence of Type 1 and Type 2 diabetes.
5. Those who are on treatment with immunosuppressive drugs and biologicals
6. Participants who are taking any other oral hypoglycaemic drugs.
7. Participants who are taking metformin for any other indication.
8.Participants who are prone to gastrointestinal symptoms like nausea, vomiting, diarrhoea, flatulence, and Vitamin B12 deficiency.
9. Pregnant and lactating women.
10. Any condition which, in the opinion of the investigator, will place the subject at risk or will influence the conduct of the study or interpretation of results.
11. Diagnosed cases of Gouty arthritis (Serum Uric acid greater than UNL).
12. Patient requiring any systemic analgesic for other conditions that can affect the outcome of the study drug.
13. Patient on systemic corticosteroid therapy.
14. Known case of history of allergy with NSAIDs or test drug.
15. Patients with a BMI greater than or equal to 40 kg/m2
16. Participants who have enrolled in any other trial in the past 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Change from baseline in Disease Activity Score-28 (DAS-28) for severity of RA at weeks 1, week 2, week 3 and week 4 |
1.Change from baseline in Disease Activity Score-28 (DAS-28) for severity of RA at weeks 1, week 2, week 3 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change from baseline in PGHA domain score for pain of affected joint at weeks 1, 2, week 3 and week 4
2. Change from baseline in the Fatigue Severity Scale (FSS) for pain at weeks 1, week 2, week 3 and week 4
3. Change from baseline in Clinical Disease Activity Index (CDAI) scores assessed at weeks 1, week 2, week 3 and week 4
4. Change from baseline in Simplified Disease Activity Index (SDAI) scores assessed at weeks 1, week 2, week 3 and week 4
5. Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) scores assessed at weeks 1, week 2, week 3 and week 4
6. Need for rescue analgesics at weeks 1, week 2, week 3 and week 4
7. Incidence of clinical adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs)
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/09/2025 |
| 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="1"
Months="0"
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
|
H0: There is no significant difference in the change in DAS-28 (CRP) scores between the study treatment (Metformin) and the reference (No metformin) treatment. H1: The change (improvement) in DAS-28 (CRP) scores is greater with the study treatment (Metformin) and reference (No metformin) treatment.
|