Native CT-II® compared with glucosamine/chondroitin and placebo for 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
This trial tests whether taking Native CT-II® capsules for 90 days helps adults with moderate knee osteoarthritis reduce pain and improve function compared with glucosamine/chondroitin or a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | Vedic Lifesciences Pvt. Ltd. Industry-sponsored |
| Locations | 5 sites (Mumbai, Maharashtra and 4 other locations) |
| Trial ID | NCT06917287 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial in Mumbai assigns people with knee osteoarthritis to one of three parallel groups: Native CT‑II® (undenatured type II collagen), glucosamine HCl plus chondroitin sulfate, or placebo. Eligible participants are 40–65 years old with Kellgren–Lawrence grade II–III knee OA, BMI 18.5–29.9, mWOMAC ≥75, and VAS pain ≥60, and they take three capsules after breakfast and three after dinner daily for 90 days. The study plans to screen about 142 people to randomize ~114 and aims for 90 completers (≈30 per group) to compare symptom changes using validated scales. The trial is conducted at three orthopedic clinics in Mumbai and is sponsored by Vedic Lifesciences Pvt. Ltd.
Who should consider this trial
Good fit: Adults 40–65 with radiographic K&L grade II–III knee OA, significant pain (VAS ≥60) and high mWOMAC scores, BMI 18.5–29.9, and who are not taking other OA medications are the intended participants.
Not a fit: People with very advanced OA (K&L grade IV), those outside the 40–65 age range, BMI outside 18.5–29.9, individuals taking other knee medications, or those with major comorbidities are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, Native CT‑II® could offer an easy-to-take oral option that reduces knee pain and improves mobility for people with moderate knee OA.
How similar studies have performed: Previous small trials of undenatured type II collagen have shown symptom improvements in osteoarthritis while glucosamine/chondroitin results remain mixed, so there is some supporting but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 1.Individuals ready to give voluntary, written informed consent to participate in the study.
2.Males and females of age between 40 to 65 years (including both values) suffering from Knee Osteoarthritis under no medications.
3.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.
6.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 -
* Grade II: Possible joint space narrowing (JSN) with definite osteophyte formation.
* Grade III: Definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends.
7.Individuals with a history of symptomatic knee joint pain of at least 3 months.
8.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.
10.Willing to stop using rescue medication 48 hours prior to every assessment visits.
11.Willing to stop the restricted dietary supplements, home-based remedies, and any other form of topical products or medications (mainly includes NSAIDs and local analgesics, DMARD, corticosteroids, etc) for knee joint pain relief or any other reason for the entire study duration.
(Note: only hot and cold fomentation will be allowed, and the participant has to record the daily frequency of fomentation in the diary. The hot/cold fomentation needs to be stopped 48 hours prior to all assessment visits.).
12.Individuals using the western toilet at home and/or workplace. 13.Willing to abstain from alcohol, caffeine, and vigorous physical activity for 24 hours before every study visit.
14.Willingness to participate and comply with the study procedures and required visits.
Exclusion Criteria:
* 1.Individuals who have been injured near the knee joint region in the past six months.
2.Individuals with a history of knee surgery, replacement or any non-knee surgical procedures that may impact the study outcomes.
3.Individuals who have used intra-articular injections, platelet replacement therapy, stem cell therapy and or steroids for joint health issues in the last six months.
4.Individuals who have any other chronic disease or condition, or inflammatory disease conditions and/ or are using any medication or dietary supplements or ayurvedic medications or topical ointment/oil/gel for joint health that in the judgment of the Investigator would put the individual at unacceptable risk for an individual in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
5.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the Investigator, would interfere with the individual's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
6.History of uncontrolled hypertension and/or systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg.
7.Fasting blood glucose (FBG) more than or equal to 126 mg/dl 8.Known cases of gout and/or hyperuricemia 9.Any history or evidence of allergy to chicken, shellfish, eggs or protein products in the past.
10.Use of collagen supplements (as dietary supplements) 11.History of bleeding disorders (e.g. Hemophilia, sickle cell anemia) 12.Other pathologic lesions on X-ray of the knee. 13.Any other condition that would prohibit completion of the exercise protocols.
14.Individuals who have participated in a clinical study with an Investigational product within 90 days before pre-screening, and who plan to participate in another study during the study period.
15.Not willing to abstain from the use of NSAIDs (including aspirin 50 mg/day for cardiovascular health).
16.Pregnant or Lactating females. 17.Individuals having a history of drug or alcohol abuse. 18.Current smokers
Where this trial is running
Mumbai, Maharashtra and 4 other locations
- Proactive Othopedic Clinic — Mumbai, Maharashtra, India (Recruiting)
- Ayush Nursing Home — Mumbai, Maharashtra, India (Recruiting)
- Diamond Orthopedic & Multispeciality Hospital — Mumbai, Maharashtra, India (Recruiting)
- O2 Clinic — Nashik, Maharashtra, India (Recruiting)
- Sparsh Superspeciality Hospital — Panvel, Maharashtra, India (Recruiting)
Study contacts
- Study coordinator: Dr Sanjay Vaze, MBBS
- Email: sanjay.v@vediclifesciences.com
- Phone: 8655670964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.