Active — Not RecruitingNot Applicable

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

India114 participantsStarted 2025-04-20

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.Males and females of age between 40 to 65 years (including both values) suffering from Knee Osteoarthritis under no medications.
.Body mass index (BMI) between 18.5 to 29.9 kg/m2 (including both values). 4.mWOMAC total score ≥ 75. 5. Individuals with knee pain having VAS score of greater than or equal to 60 mm on a 100 mm VAS scale.
.Radiographic evidence (lateral and anterio-posterior weight-bearing standing X-ray) of grade II/III (in 2: 1 ratio) knee Osteoarthritis (OA) for index joint (The knee with the higher pain score will be designated as the index joint for the study) based on the Kellgren and Lawrence (K\&L) radiographic entry criteria for OA -
.Individuals with a history of symptomatic knee joint pain of at least 3 months.
.Non-vegetarians (regardless of whether they eat chicken, fish, goat mutton, pork, beef or eggs) 9.Willing to abstain from food (fish, meat, bone broth, eggs, etc) containing Type II collagen from cartilage 48 h before all assessment visits.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the effect of consumption of Native CT-II on knee joint health asassessed by change in modified Western Ontario and McMaster UniversityOsteoarthritis Index total score as compared to baseline,Glucosamine HCL + Chondroitin Sulphate an

Timeframe: day 0, day 7, day 30, day 60 and day 90

Trial details

NCT IDNCT06917287

SponsorVedic Lifesciences Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-26

View on ClinicalTrials.gov More Knee Osteoarthritis (OA) trials

Plain-language summary

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.Males and females of age between 40 to 65 years (including both values) suffering from Knee Osteoarthritis under no medications.
.Body mass index (BMI) between 18.5 to 29.9 kg/m2 (including both values). 4.mWOMAC total score ≥ 75. 5. Individuals with knee pain having VAS score of greater than or equal to 60 mm on a 100 mm VAS scale.
.Radiographic evidence (lateral and anterio-posterior weight-bearing standing X-ray) of grade II/III (in 2: 1 ratio) knee Osteoarthritis (OA) for index joint (The knee with the higher pain score will be designated as the index joint for the study) based on the Kellgren and Lawrence (K\&L) radiographic entry criteria for OA -
.Individuals with a history of symptomatic knee joint pain of at least 3 months.
.Non-vegetarians (regardless of whether they eat chicken, fish, goat mutton, pork, beef or eggs) 9.Willing to abstain from food (fish, meat, bone broth, eggs, etc) containing Type II collagen from cartilage 48 h before all assessment visits.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria