Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: 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-R
Sponsors
Biocorp
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in WOMAC total score 2. Change in VAS pain scoreTimepoint: 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
| Measure | Time frame |
|---|---|
| 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)Timepoint: 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 | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed