A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis
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.
• 1.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.