Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in S… (NCT04765189) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in Subjects Suffering From Osteoarthritis Grade I or II
Spain95 participantsStarted 2021-03-01
Plain-language summary
The aim of the present investigation is to evaluate the efficacy of Mangoselect®, a mangosteen extract, and of a formulation containing Mangoselect®, in subjects suffering from activity/exercise-induced knee joint pain/discomfort, during a 12-week supplementation period. Subjective discomfort improvement will be assessed with both WOMAC questionnaire and pain Visual Analogic Scale (VAS); functional joints features, quality of life, and inflammatory markers, will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after the end of the supplementation period. The design of the study is double-blind, randomized, multi-arm, parallel and placebo controlled.
Who can participate
Age range
50 Years – 75 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 volunteers
* BMI 22-29.9 kg/m2
* Declaring knee joint pain during and/or after activity/exercise
* Joint knee pain rated of at least 4 cm on a 10 cm VAS following activity/exercise
* Diagnosed osteoarthritis grade I or II according to Kellgren-Lawrence classification
Exclusion Criteria:
* Diagnosed inflammatory joint disorder or osteoarthritis grade III or more according to Kellgren-Lawrence classification
* Currentlu chronically taking pain killer drugs or dietary supplement or intra-articular treatment 3 months before selection
* Anemia
* Subjects with knee/joint surgery/replacement in the past 10 years
* Significant injury of the studied knee joint 12 months before selection
* Unable to carry out functional tests and/or questionnaires
* Currently participating or having participated in another clinical trial in the 3 previous months
* Pregnant women and women positive at Beta-HCG serology test
* Any condition that the investigator believes would interfere with the ability to provide inform consent, or comply with study instructions, or confound the interpretations of the study results, or put the volunteer at undue risk
* Allergy to one of the component of the supplements
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
Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Timeframe: 12 weeks
2
Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm