NCT06917287

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Knee Osteoarthritis (OA)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Native CT-II® (undenatured type II collagen)	Strength: 40 mg in 3 capsules Dose Regimen: 3 yellow capsules containing MCC after breakfast with water 3 blue capsules containing 40 mg Native CT-II® \& MCC after dinner with water Route of administration: Oral
DIETARY_SUPPLEMENT	Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator]	2700 mg (1500 mg G + 1200 mg C) 3 yellow capsules containing G+C orally after breakfast with water \& 3 blue capsules containing G+C after dinner with water
DIETARY_SUPPLEMENT	Placebo [Microcrystalline Cellulose (MCC)	2700 mg excipient 3 yellow capsules containing MCC orally after breakfast with water 3 blue capsules containing MCC after dinner with water.

Timeline

• Start date: 2025-04-20
• Primary completion: 2026-02-15
• Completion: 2026-02-15
• First posted: 2025-04-08
• Last updated: 2026-01-22

Locations

5 sites across 1 country: India