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 range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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'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