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RECRUITING
NCT06917287
NA

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

Sponsor: Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-04-20

Completion Date

2026-02-15

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

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.

Locations (5)

Proactive Othopedic Clinic

Mumbai, Maharashtra, India

Ayush Nursing Home

Mumbai, Maharashtra, India

Diamond Orthopedic & Multispeciality Hospital

Mumbai, Maharashtra, India

O2 Clinic

Nashik, Maharashtra, India

Sparsh Superspeciality Hospital

Panvel, Maharashtra, India