| CTRI Number |
CTRI/2025/08/093408 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on Participants with Mild to Moderate Knee Osteoarthritis to Assess the Outcome of Adding Metformin (1000 mg/day) as an Intervention Alongside Standard Treatment" |
|
Scientific Title of Study
|
Efficacy and Safety of Metformin (1000 mg/d) as Adjuvant to Standard of Care (SOC) in Management of Mild to Moderate Osteoarthritis (OA) of Knee: A Prospective, Randomized, Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DYP/IECBH/2025/175; Version 1.0, dt. 01-07-2025 |
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 ,D.Y. Patil Hospital, deemed to be University , Navi Mumbai.
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 |
Department of pharmacology ,5 th floor,D.Y. Patil deemed to be University School of Medicine, Navi Mumbai.
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 |
Department of pharmacology ,5 th floor,D.Y. Patil deemed to be University School of Medicine, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9082895271 |
| Fax |
|
| Email |
adwait.malik.01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
D.Y. PATIL Deemed to be University School of Medicine, Navi Mumbai |
| Address |
Department of Pharmacology, 5th floor, plot No 2, Sector-5, Nerul, Navi Mumbai- 400706 |
| 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. 400706 |
Orthopaedics department 3rd floor, room no. 301, OPD number 22 .
Thane
MAHARASHTRA |
9821431687
sachin.kale@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
METFORMIN DRUG |
Oral Metformin (500 mg) twice daily after meals (breakfast and dinner)for a total duration of 4 weeks. |
| Comparator Agent |
placebo tablets 500 mg tablets |
Placebo calcium tablets 500 mg BD for a total duration of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients aged between 30 to 70 years.
2. Clinically diagnosed and radiologically confirmed mild to moderate (Kellgren Lawrence grade II and III) symptomatic cases of Osteoarthritis of the knee joints.
3. Onset of symptom duration greater than or equal to 6 months at the time of screening.
4. Greater than or equal to 5 score on a 10-point visual analogue scale (VAS) for pain at baseline.
5. Willing to give consent for participating in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients having severe (Kellgren lawrence grade IV)/ disabling arthritis in the targeted or contralateral knee joint.
2. Patients with radiologically abnormal knee alignment.
3. Those who are suffering from skin-related problems at the local sites of drug application, which may be affected the drug application.
4. Patients with a history of Chikungunya, Dengue, or other viral infections in the past six months.
5. Participants with a history or presence of Type 1 and Type 2 diabetes.
6. Those who are on treatment with immunosuppressive drugs and biologicals
7. Participants who are taking any other oral hypoglycaemic drugs.
8.Participants who are taking metformin for any other indication.
9. Participants who are prone to gastrointestinal symptoms like nausea, vomiting, diarrhea, and flatulence Vitamin B12 deficiency.
10. Pregnant and lactating women
11. Any condition which, in the opinion of investigator, will place the subject at risk or will influence the conduct of study or interpretation of results
12. Diagnosed cases of Rheumatoid arthritis (RA factor positive) and Gouty arthritis (Serum Uric acid greater than UNL)
13. Patient requiring any systemic analgesic for other conditions that can affect the outcome of the study drug
14.Patient on systemic corticosteroid therapy
15. Known case of history of allergy with NSAIDs or test drug.
16.Patients with BMI greater than or equal to 40 kg/m2.
17. 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 |
| Change in pain severity from baseline, measured using the pain subscale of the Oxford Knee Score (OKS), in participants with mild to moderate knee osteoarthritis receiving the intervention. |
Pain assessment using OKS at Week 1, Week 2, Week 3, and Week 4 following initiation of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in range of motion (ROM) of the affected knee joint from baseline, measured using goniometry.
Change in pain intensity from baseline, assessed using the 10-point Visual Analogue Scale (VAS).
Change in Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline, reflecting improvements in pain, symptoms, function, & quality of life.
Frequency & quantity of rescue analgesic use, indicating additional pain management needs.
Incidence of adverse events (AEs), treatment-emergent adverse events (TEAEs), & serious adverse events (SAEs) during the study period. |
Week 1, Week 2, Week 3, & Week 4 post-initiation of intervention for all secondary outcomes listed above. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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
|
For continuous variables number of
non-missing observations (n), mean, standard deviation (SD), median, maximum,
and minimum (range) will be presented.
For discrete and categorical variables, data
will be expressed as numbers with percent values.
All analyses will be done using two-sided
tests at alpha 0.05 (95% confidence level).
H0: There is no significant difference in the change in OKS
scores between the study treatment (Metformin) and the reference (No metformin)
treatment.
H1: The change (improvement) in OKS scores is greater with the
study treatment (Metformin) and reference (No metformin) treatment.
|