A Randomized, Double-Blind, Placebo-controlled, Parallel Design Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion \& Joint Discomfort in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
375
4 capsules per day
4 capsules per day
4 capsules per day
HOS Hospital
Ahmedabad, Gujarat, India
NOT_YET_RECRUITINGShalby hospital
Surat, Gujarat, India
RECRUITINGAman Hospital and Research Centre
range of motion (active flexion and extension)
To evaluate the efficacy of collagen on knee joint flexibility as assessed by the change in the range of motion (active flexion and extension) using goniometry as compared to placebo.
Time frame: from baseline Day 0 to end of study visit day 180
range of motion knee joint flexibility
Change in the knee joint flexibility (Knee ROM Extension) as assessed by a range of motion (using goniometry) in the Collagen groups versus the other groups
Time frame: from baseline (day 0) to end of study visit (day 180)
Pain visual analog scale
Knee joint pain as assessed by Pain visual analog scale at the end of the stress exercise in Collagen groups versus the placebo and the Glucosamine \& Chondroitin group. 0 - No pain at all 100 - worst possible pain
Time frame: from baseline (Day 0) to Day 5, 30, 60, 90, 120, 150 and 180
Knee injury and Osteoarthritis Outcome Score
Retrospective Joint Discomfort as assessed by the change in the Knee injury and Osteoarthritis Outcome Score as compared in the Collagen groups compared to placebo and Glucosamine \& Chondroitin. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0- 100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic scales and generic measures. Scores between 0 and 100 represent the percentage of the total possible score achieved
Time frame: from baseline (Day 0) (post-exercise) to follow up visit Day 5, 30, 60, 90, 120, 150 and day 180 (post-exercise)
European Quality of Life Five Dimension five-level
Quality of life (QoL) as assessed by change in European Quality of Life Five Dimension five-level score as compared to the change into placebo and Glucosamine \& Chondroitin groups Lower level is denoted as 1 and the highest level is denoted as 5
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4 capsules per day
4 capsules per day
Vadodara, Gujarat, India
BLDEU Hospital and research center
Vijayapura, Karnataka, India
NOT_YET_RECRUITINGShree Ashirwad Hospital
Dombivali, Maharashtra, India
RECRUITINGSurya Hospital
Nashik, Maharashtra, India
RECRUITINGRanka Hospital
Pune, Maharashtra, India
RECRUITINGJivanrekha Hospital
Pune, Maharashtra, India
RECRUITINGBAJ RR Hospital
Thane, Maharashtra, India
RECRUITINGJaipur National University Institute of Medical Sciences and Research Center
Jaipur, Rajasthan, India
RECRUITINGTime frame: from baseline (Day 0) to the end of the study (day 180)