Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
None listed
Sponsors
Nitta Gelatin India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for the study, Participants must meet the following criteria: 1. Male or female participants aged between 40 to 70 years at the time of screening 2. Clinically diagnosed with primary knee osteoarthritis, confirmed by Kellgren Lawrence grade 1 or 2 on radiographic assessment. 3. Participants must provide a knee X-ray performed within the last 03 months or undergo a new X-ray at screening. 4. WOMAC Pain Score greater than or equal to 20 (on the standardized scale used at the site) at screening. 5. Participant must have knee pain with a Visual Analogue Scale (VAS) score greater than or equal to 40 mm on a 100-mm scale at screening. 6. BMI greater than or equal to25 kg/m at screening 7. No use of intra-articular corticosteroids, systemic corticosteroids, collagen supplements, or other investigational nutraceuticals/therapies for at least 3 months prior to screening. 8. Participants who are willing and able to comply with all study visits, treatment, and procedures throughout the study duration. 9. Participants willing to discontinue prohibited pain medications prior to baseline assessment, as per protocol requirements. 10. Women of childbearing potential must not be breastfeeding must have a negative urine pregnancy test at baseline and agree to use effective contraception through the study period. 11. Written informed consent obtained before any study-related procedure. 12. Overall health status deemed acceptable by the investigator based on medical history, physical examination, and baseline laboratory assessments.
Exclusion criteria
Exclusion criteria: Participants with any of the following conditions will be excluded from the study: 1. Diagnosis of rheumatoid arthritis, gout, psoriatic arthritis, or any other inflammatory or secondary joint disease affecting the knee. 2. History of knee surgery, significant knee trauma, or arthroscopic procedures within the past 06 months 3. Any condition that may interfere with knee function assessment as per investigator judgment. 4. Use of glucosamine, chondroitin, collagen supplements, or any investigational nutraceutical within the past 03 months 5. Use of intra-articular corticosteroids, systemic steroids, or hyaluronic acid injections within 03 months prior to screening 6. History or presence of severe cardiac, renal, or hepatic disease, or any other medical condition that, in the opinion of the investigator, may compromise the participant s safety or interfere with study assessments. 7. Any illness or condition that may conflict with the investigator s interpretation of safety or efficacy endpoints, or limit compliance with study procedures. 8. Participation in another clinical drug trial or interventional study within 3 months prior to screening. 9. Current alcohol or drug abuse, or a documented history of alcohol or substance abuse within 12 weeks (approximately 03 months) prior to baseline. 10. Pregnant or lactating women or women planning a pregnancy during the clinical study 11. Women of childbearing potential who are unwilling or unable to use effective contraception throughout the study period. 12. Any condition that, in the investigator s judgment, renders the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC total score including subscales of pain stiffness and physical function. Change in VAS pain score. Change in Lequesne Index for joint function. Change in 6-Minute Walk Test distance. Change in knee Range of Motion, measured using standardized goniometry Change in inflammatory and cartilage degradation biomarkersTimepoint: Time Frame: (Baseline, Week4, Week 8, Week 12) Time Frame: (Baseline, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SF-36 Health Survey Score, including all physical & mental health domains. Quality of Life Documentation (Photographic Assessment): Evaluation of visual improvement through standardized photographs (Change in X ray images) in 03 to 05 participants per treatment group. Changes in Clinical Laboratory Parameters. Adverse Events (AE) & Serious Adverse Events (SAE): Incidence, severity, & relationship to study product reported throughout the study duration.Timepoint: Time Frame: (Baseline, Week4, Week 8, Week 12) Time Frame: (Baseline, Week 12) | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd.
Outcome results
None listed