NCT05212259
Recruiting
Not Applicable
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
ConditionsJoint Pain
Overview
- Phase
- Not Applicable
- Intervention
- Collagen type II (40 mg/day)
- Conditions
- Joint Pain
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 375
- Locations
- 10
- Primary Endpoint
- range of motion (active flexion and extension)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Physically active male and female both, aged ≥ 20 to ≤ 65 years with the daily routine of physical exercise (exercise such as walking, jogging, running, cycling, climbing stairs, squatting or any other exercise on investigator's discretion that involves knee joint movement) for at least 3 days a week.
- •Subject with a history of 4-9 months related to knee joint pain aggravation on physical stress.
- •Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m
- •Fasting blood glucose (FBG) ≤ 125 mg/ dl.
- •Subject with self-reported joint pain of ≥ 70 mm on a 100-point VAS scale after 10±2 minutes of walking on a treadmill using modified Naughton protocol.
- •Subject with pain ≤30 mm at rest on Pain VAS
- •Subject not diagnosed as a case of OA / RA confirmed by the American college of rheumatology (ACR) criteria.
- •The subject is willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements.
- •The subject is willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period.
- •Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
Exclusion Criteria
- •Obese Subject with BMI \> 29.9 kg/m
- •Subject's inability to complete the exercise protocol of 10±2 minutes at screening.
- •Subject with the clinical diagnosis of any form of joint disease such as Osteoarthritis (OA).
- •Subject with the clinical diagnosis of any form of autoimmune disorder related to the joint such as Rheumatoid arthritis (RA).
- •A subject suffering from Insomnia and restless leg syndrome.
- •Uncontrolled hypertensive defined as subject currently on an anti-hypertensive drug with systolic Blood Pressure ≥ 140 mm Hg and/ or \& diastolic blood pressure ≥ 90 mm Hg
- •Uncontrolled diabetics currently on anti-diabetic medication with Fasting blood glucose (FBG) ≥ 126 mg/ dl.
- •Systolic Blood Pressure ≥ 140 mm Hg and/ or \& diastolic blood pressure ≥ 90 mm Hg
- •The subject who have been injured near the knee joint region in the past six months.
- •Subject with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes.
Arms & Interventions
Collagen type II (40 mg/day)
4 capsules per day for 180 days
Intervention: Collagen type II (40 mg/day)
Collagen type II (80 mg/day)
4 capsules per day for 180 days
Intervention: Collagen type II (80mg/day)
Collagen type II (120 mg/day)
4 capsules per day for 180 days
Intervention: Collagen type II (120 mg/day)
Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg)
4 capsules per day for 180 days
Intervention: Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg)
Placebo
4 capsules per day for 180 days
Intervention: Placebo
Outcomes
Primary Outcomes
range of motion (active flexion and extension)
Time Frame: from baseline Day 0 to end of study visit day 180
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.
Secondary Outcomes
- European Quality of Life Five Dimension five-level(from baseline (Day 0) to the end of the study (day 180))
- range of motion knee joint flexibility(from baseline (day 0) to end of study visit (day 180))
- Pain visual analog scale(from baseline (Day 0) to Day 5, 30, 60, 90, 120, 150 and 180)
- Knee injury and Osteoarthritis Outcome Score(from baseline (Day 0) (post-exercise) to follow up visit Day 5, 30, 60, 90, 120, 150 and day 180 (post-exercise))
Study Sites (10)
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