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

NCT06917287 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-01-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-20
Primary Completion
2026-02-15
Completion
2026-02-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917287 on ClinicalTrials.gov