Actively Recruiting

Phase Not Applicable
Age: 40Years - 65Years
All Genders
NCT06917287

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

Led by Vedic Lifesciences Pvt. Ltd. · Updated on 2026-01-22

114

Participants Needed

5

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 65 years with knee osteoarthritis not currently on medication
  • Body mass index between 18.5 and 29.9 kg/m2
  • Modified WOMAC total score of 75 or higher
  • Knee pain with a visual analog scale score of 60 mm or more
  • Radiographic evidence of grade II or III knee osteoarthritis
  • History of symptomatic knee joint pain lasting at least 3 months
  • Non-vegetarian diet
  • Willingness to avoid foods containing type II collagen 48 hours before assessments
  • Willingness to stop rescue medication 48 hours before assessments
  • Willingness to stop other supplements, remedies, and topical treatments for knee pain during the study
  • Use of western toilet at home or workplace
  • Willingness to abstain from alcohol, caffeine, and vigorous physical activity 24 hours before study visits
  • Ability and willingness to comply with study procedures and visits
Not Eligible

You will not qualify if you...

  • Knee injury within the past 6 months
  • History of knee surgery or joint replacement
  • Use of intra-articular injections, platelet therapy, stem cell therapy, or steroids for joint issues in the past 6 months
  • Presence of other chronic or inflammatory diseases or use of medications/supplements that may interfere with the study
  • Significant kidney, liver, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders
  • Uncontrolled hypertension (blood pressure ≥140/90 mmHg)
  • Fasting blood glucose ≥126 mg/dl
  • Known gout or hyperuricemia
  • Allergy to chicken, shellfish, eggs, or protein products
  • Use of collagen supplements
  • History of bleeding disorders
  • Other pathological knee lesions on X-ray
  • Conditions preventing completion of exercise protocols
  • Participation in another clinical trial within 90 days before screening
  • Unwillingness to abstain from NSAIDs including low-dose aspirin
  • Pregnant or breastfeeding women
  • History of drug or alcohol abuse
  • Current smokers

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Proactive Othopedic Clinic

Mumbai, Maharashtra, India, 400053

Actively Recruiting

2

Ayush Nursing Home

Mumbai, Maharashtra, India, 400067

Actively Recruiting

3

Diamond Orthopedic & Multispeciality Hospital

Mumbai, Maharashtra, India, 400067

Actively Recruiting

4

O2 Clinic

Nashik, Maharashtra, India, 422005

Actively Recruiting

5

Sparsh Superspeciality Hospital

Panvel, Maharashtra, India, 410206

Actively Recruiting

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Research Team

D

Dr Sanjay Vaze, MBBS

CONTACT

D

Dr. Asha More, BAMS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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