Abstract
Background
Osteoarthritis (OA) of the knee is the most common type of arthritis, increasing with advancing age and external factors such as obesity. Joint health has historically relied on nutritional supplements derived from herbs and other natural products. Undenatured collagen type II demonstrated positive results with substantially lower therapeutic doses. Hence, the present study was designed to determine the efficacy and safety of Native CT-II®, an undenatured type II collagen, on the symptomatic effects in individuals having joint pain due to OA.
Methods
A randomized, double-blinded, placebo-controlled, parallel study was conducted on 101 slightly overweight volunteers, whose knee joint pain VAS score was ≥ 60 had been included in the study for at least three months. The participants were divided into three groups, with similar demographic and baseline characteristics. The test product containing Native CT-II®, positive control containing G+C, and the placebo were taken six tablets per day for 84 consecutive days (Three capsules to be taken post-breakfast and three capsules post-dinner). Improvement in overall joint health in each participant from baseline to end of the study was measured by WOMAC, self-administered questionnaire in Native CT-II® as compared to G+C and placebo group.
Results
This study demonstrated that Native CT-II® had an effective impact on the symptomatic effects of knee impairment associated with OA and in the quality of life of the participants. After 84 days, participants receiving Native CT-II® and G+C had significant improvement in overall joint health as compared to participants receiving placebo.
Conclusion
Native CT-II® was shown to be effective in relieving symptoms and improving quality of life for patients with knee joint pain associated with OA.
Trial registration:
The trial was registered with the clinical trial registry of the U.S. National Library of Medicine under National Institutes of Health (NIH) (https://clinicaltrials.gov/) with the National Clinical Trial (NCT) No: NCT04470336, Date of first registration: 14/07/2020.