A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Jul 15, 2026 to Mar 26, 2026
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised at 1 of 5 sites
    • Eligibility criteria expanded, about 4 words
  2. Minor Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from Feb 15, 2026 to Mar 26, 2026
    • Study completion pushed from Feb 15, 2026 to Jul 15, 2026
    • Site details revised at 5 of 5 sites
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Dec 15, 2025 to Feb 15, 2026
    • Study completion date: Dec 31, 2025 to Feb 15, 2026
    • Start date changed from estimate of Jun 15, 2025 to Apr 20, 2025
    • Study sites revised (5)
  4. Notable Start date: Apr 15, 2025 to Jun 15, 2025v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy of Native CT-II® (undenatured type II collagen) in individuals with knee osteoarthritis using a parallel design.Participants are assigned to one of three groups: Group 1 receives Native CT-II® (40 mg daily individed doses), Group 2 receives Glucosamine HCL + Chondroitin Sulphate (2700 mg daily as acomparator), and Group 3 receives a placebo (Microcrystalline Cellulose). All participants take threecapsules after breakfast and three after dinner for 90 days . The study aims to screen approximately 142 participants , randomizing around 114 (considering a 20% dropout rate), with a target of 90completed participants (30 per group). Osteoarthritis (OA) is a degenerative joint disorder causing pain, stiffness, and reduced mobility,primarily affecting older adults. It is a leading cause of disability, with knee OA being the mostprevalent form. The global burden of OA is rising due to aging populations and increasing obesityrates, necessitating improved treatment options. Current management focuses on symptom reliefthrough non-pharmacological (exercise, weight loss) and pharmacological (NSAIDs, analgesics)interventions, though these can have adverse effects. Undenatured type II collagen (NCTII), derived from chicken sternum, has emerged as a potentialsupplement for joint health. It triggers an immune response that reduces inflammation and supportscartilage repair. Clinical studies show that NCTII improves joint function, pain, and quality of life,outperforming glucosamine and chondroitin with fewer side effects. A new study aims to evaluatethe efficacy of Native CT-II® in individuals with Grade II and III knee OA over 90 days, comparing itto glucosamine-chondroitin and placebo groups.
Trial Details
NCT Number NCT06917287
Lead Sponsor Vedic Lifesciences Pvt. Ltd.
Conditions
(from sponsor)
Knee Osteoarthritis (OA)
Related terms Osteoarthritis, Knee
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov