Efficacy and Safety of b-2Cool on Adults With Joint Discomfort (NCT02843620) | Clinical Trial Compass
WithdrawnNot Applicable
Efficacy and Safety of b-2Cool on Adults With Joint Discomfort
Stopped: Enrollment not started
0Started 2018-07
Plain-language summary
This study evaluates the effects of 40 mg of b-2Cool, a food supplement rich in native type-II collagen, on healthy adults with joint discomfort. Half of the participants will receive the b-2Cool containing supplement while the other half will receive a placebo pill.
Who can participate
Age range40 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults between 40 and 75 years old.
* Subject who suffers mild joint discomfort (value between 3 and 5 VAS scale for a minimum of 6 months).
* Subject that after reading and understanding the study's protocol has provided written informed consent to participate in the study.
* Subjects willing to keep stable eating and activity patterns during the duration of the study.
* Subjects who use other therapies for joint discomfort, such as exercise, heat / cold, joint protection and physiotherapy / occupational therapy agree to follow the treatments avoiding changes in the frequency or intensity of them and reporting them at baseline and during follow-ups.
* Subjects agree not start any new therapy during the study period.
* Subjects who have lateral or longitudinal knee synovial effusion according to the index OMERACT (Outcome Measures in Rheumatology) .
Exclusion Criteria:
* Active rheumatoid arthritis, diagnosed osteoarthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
* Being pregnant or lactating.
* Be waiting for joint surgery or major surgery in the next 8 months
* Joint injury in the last 4 months in the area osteoarthritis-affected (i.e. meniscal tear)
* Having underwent reconstructive surgery on the cartilage of the affected knee
* Background of peptidic ulcer and other symptomatic/active disorders of the intestinal tract that may interfere with product under evaluation .
* History of congestive heart …
What they're measuring
1
Change from baseline of ultrasonographic assessment of synovial effusion