Status:
NOT_YET_RECRUITING
A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Knee Osteoarthritis (OA)
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief 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....
Eligibility Criteria
Inclusion
- Individuals ready to give voluntary, written informed consent to participate in the study.
- 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 -
- 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.
- 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.
- Willing to stop using rescue medication 48 hours prior to every assessment visits.
- 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.).
- 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.
- Willingness to participate and comply with the study procedures and required visits.
Exclusion
- Individuals who have been injured near the knee joint region in the past six months.
- Individuals with a history of knee surgery, replacement or any non-knee surgical procedures that may impact the study outcomes.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Not willing to abstain from the use of NSAIDs (including aspirin 50 mg/day for cardiovascular health).
- Pregnant or Lactating females. 17.Individuals having a history of drug or alcohol abuse. 18.Current smokers
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06917287
Start Date
June 15 2025
End Date
December 31 2025
Last Update
May 28 2025
Active Locations (5)
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1
Proactive Othopedic Clinic
Mumbai, Maharashtra, India, 400053
2
Ayush Nursing Home
Mumbai, Maharashtra, India, 400067
3
Diamond Orthopedic & Multispeciality Hospital
Mumbai, Maharashtra, India, 400067
4
Life Care Hospital
Nashik, Maharashtra, India, 422009