| CTRI Number |
CTRI/2026/01/100265 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to check if the Nutraceutical Product can reduce the joint pain and is safe when used by the participants suffering with mild osteoarthritis |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Center Clinical Study To Evaluate The Safety And Efficacy Of Orally Administered Nutraceutical Product In Participants With Mild Osteoarthritis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2513 Version No. 1.0 Dated 25/Oct/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharadwaj G K |
| Designation |
Principal Investigator |
| Affiliation |
Currex Hospital |
| Address |
No.55-56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli, KS Halli,
Bangalore Karnataka
560049
India
Bangalore
KARNATAKA
560049
India |
| Phone |
09900282899 |
| Fax |
|
| Email |
bharadwajgk938@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi L M |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204,Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block Bangalore
Bangalore
KARNATAKA
560069
India
Bangalore
KARNATAKA
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Mamatha B Gokavi |
| Designation |
Project Manager |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204,Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
mamatha@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Biocorp
181-28 Joseong-ro, Joseong-myeon, Boseong-gun, Jeollanam-do |
|
|
Primary Sponsor
|
| Name |
Biocorp |
| Address |
181-28 Joseong-ro, Joseong-myeon,
Boseong-gun, Jeollanam-do 59432
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Bharadwaj G K |
Currex Hospital |
Ground Floor, OPD 5, No. 55, 56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli, KS Halli
Bangalore
KARNATAKA |
06364898825
bharadwajgk938@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
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
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Identical softgel capsule containing inert edible oil (e.g., medium-chain triglycerides or mineral oil), matched for size, shape, color, appearance, and packaging to the investigational product, administered once daily after dinner for 12 weeks |
| Intervention |
SPMs-Enriched Oil Softgel Capsule (500 mg) |
SPMs-Enriched Oil Softgel Capsule, an oral soft gelatin capsule containing a proprietary lipid-based formula with bioactive Specialized Pro-Resolving Mediators (SPMs), derived from omega-3 fatty acids (EPA/DHA). Dose: One 500 mg softgel capsule per day, to be taken once daily after dinner with water, for a duration of 12 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 40 to 75 years inclusive at the time of screening
2. Clinically diagnosed primary knee osteoarthritis in one or both knees confirmed radiographically as Kellgren Lawrence Grade 1 or 2 in the index knee
3. VAS score for knee pain of more than or equal to 30 millimetre or more on a 100 millimetre Visual Analogue Scale (VAS) at screening
4. Body Mass Index between 20 and 29.9 kilogram per meter square inclusive
5. Osteoarthritis symptoms present for at least 3 months prior to screening
6. On stable doses of chronic medications (if any) for more than or equal to 4 weeks before screening
7. Willing and able to follow study requirements including daily product intake, completion of visit assessments, and follow-up procedures over the 6-month study period
8. Able to understand the study procedures and provide written informed consent approved by the Ethics Committee
9. Women of childbearing potential must agree to use an acceptable contraceptive method during the study and have a negative pregnancy test at screening |
|
| ExclusionCriteria |
| Details |
1. Inflammatory arthritis including diagnosed rheumatoid arthritis psoriatic arthritis gout or any other autoimmune or inflammatory joint disease
2. Secondary osteoarthritis due to trauma congenital abnormalities metabolic disorders or endocrine disorders
3. Severe osteoarthritis defined as Kellgren Lawrence Grade 3 or 4 in the index knee
4. History of knee joint replacement or planned knee surgery during the study period
5.Intra articular injection of corticosteroids hyaluronic acid or platelet rich plasma in the index knee within 3 months prior to screening
6. Prohibited medication use including
-Use of non steroidal anti inflammatory drugs or COX 2 inhibitors within 3 weeks prior to baseline
-Use of opioid analgesics within 3 weeks prior to baseline
-Use of joint specific supplements such as glucosamine chondroitin or omega 3 supplements initiated within 4 weeks prior to screening
7. Known allergy or hypersensitivity to seafood fish oil or any component of the investigational product or placebo
8. Body Mass Index 30 kilogram per meter square or above at screening
9. Significant medical conditions including
-Clinically relevant hepatic or renal dysfunction(example: ALT/AST greater than 2.0 multiplied ULN: eGFR less than 50 mL per minute per 1.73 meter square)
-Uncontrolled hypertension(example: BP more than 160/100 mmHg)
-History of myocardial infarction stroke or unstable cardiovascular disease within the last 6 months
-Active peptic ulcer disease or gastrointestinal bleeding
10. Cognitive impairment or psychiatric disorders that could interfere with study participation or informed consent
11. Substance use history
-History of alcohol or drug abuse in the past 12 months
- Heavy smoking defined as more than 20 cigarettes per day or equivalent tobacco consumption
12. Participation in another interventional clinical trial within 3 months prior to screening
13. Women who are pregnant lactating or planning pregnancy during the study period
14. Any other condition that in the investigator opinion could compromise participant safety study conduct or data integrity |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in WOMAC total score
2. Change in VAS pain score |
Visit 2 (Day 1),Visit 3 (Day 28 ± 3 days), Visit 4 (Day 56 ± 3 days), Visit 5 (Day 84 ± 5 days
Visit 1(Day -7 to -1), Visit 2 (Day 1),Visit 3 (Day 28 ± 3 days), Visit 4 (Day 56 ± 3 days), Visit 5 (Day 84 ± 5 days, Visit 6 Day 168 ± 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in WOMAC subscale scores
2. OMERACT-OARSI responder rate
3. Change in EQ-5D-5L index and VAS
4. Self-reported physical activity and sleep impact (exploratory)
5. Durability of effect (VAS/WOMAC global impression) |
Visit 2 (Day 1), Visit 3 (Day 28 ± 3 days), Visit 4 (Day 56 ± 3 days) and Visit 5 (Day 84 ± 5 days)
Visit 2 (Day 1) and Visit 5 (Day 84 ± 5 days)
Visit 2 (Day 1) and Visit 5 (Day 84 ± 5 days)
Visit 5 (Day 84 ± 5 days) and Visit 6 Day 168 ± 7 days
Week 12 |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
12/01/2026 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Introduction
Osteoarthritis is a common joint disorder that causes cartilage loss, changes in the underlying bone, inflammation, and chronic pain, especially affecting the knee in adults over 50. Standard treatments such as pain medicines, physical therapy, and surgery often have limitations including side effects or inadequate relief. Specialised pro resolving mediators or SPMs are natural compounds derived from omega 3 fatty acids that help resolve inflammation and support tissue repair without affecting the immune system. Early studies suggest that SPM enriched oils may improve pain, movement, and quality of life in people with osteoarthritis, but data in the Indian population are limited. Purpose of the Study
This study aims to evaluate the safety and effectiveness of a daily 500 mg SPM enriched oil supplement in adults with mild knee osteoarthritis. The study will assess whether taking the supplement can improve joint pain, stiffness, physical function, and overall quality of life while monitoring safety and tolerability. The results will provide evidence to support health claims and offer a safe, non invasive option for managing early stage osteoarthritis. Study DesignThis is a randomized, double-blind, placebo-controlled, two-arm, single-center trial. A total of 110 adults (40–75 years) with mild knee OA (Kellgren–Lawrence Grade 1–2) will be randomized 1:1 to receive:
Treatment will continue for 12 weeks, with follow-up for another 12 weeks to monitor safety, compliance, and persistence of effects. Assessments will be at baseline, monthly visits, end of treatment, and a telephonic follow-up at Month 6. |