Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range o… (NCT05212259) | Clinical Trial Compass
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Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects
India375 participantsStarted 2022-10-10
Plain-language 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
Who can participate
Age range20 Years – 65 Years
SexALL
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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/m2.
✓. 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.
Exclusion criteria
✕. Obese Subject with BMI \> 29.9 kg/m2.
✕. 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).
What they're measuring
1
range of motion (active flexion and extension)
Timeframe: from baseline Day 0 to end of study visit day 180
. 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