Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT06714851
Eligibility Criteria:
Inclusion Criteria:
* Body mass index ≥ 18.5 and \< 30.0 kg/m2.
* Physically active: joint bearing sports (i.e., but not limited to soccer, basketball, handball, volleyball, tennis, running) for at least 3 hours per week or 2 times per week.
* Who self-report activity-related discomfort or reversible knee-joint discomfort during or immediately after physical activity over a period of at least 2 months.
* Who experience pain intensity of 5 (out of 10 on the 11 point-NRS) during the stress joint test (SLSD) and perform at least 25 repetitions.
* Who have no trouble swallowing capsules
* Having a smartphone allowing using the e-PRO App NursTrial®.
* Affiliated to a French Health insurance scheme.
* Signed informed consent.
Exclusion Criteria:
* With diagnosed injury/trauma or tendinopathy (wiper syndrome, patellofemoral syndrome, meniscopathy), algodystrophy, osteoarthritis, rheumatic arthritis or inflammation, or other knee or joint disease.
* Extreme pain symptoms that required high-dose analgesic therapy over a longer period (\>2 weeks) or intra-articular injection treatment.
* Untreated or unstable hypothyroidism, or evidence of any neurological disorders.
* Known hypersensitivity to one of the components of the experimental products (i.e., dog rose).
* Intra-articular injections or infiltrations with hyaluronic acid, plasma-rich platelet, glucosamine, chondroitin, or supplementation, with glucosamine, chondroitin, collagen-based products in the last 3 months, or spa therapy related to join health in the last 6 months.
* Current intake of corrective treatment, plant-based products or dietary supplements that could interfere with joint, tendon or bone metabolism.
* May not be compliant or may not respect the constraints imposed by the protocol (i.e., stable physical activities and dietary habits throughout the study).
* Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.
* For woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized): not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
* Belonging to a population covered by articles L.1121-5 (pregnant confirmed by urinary test at inclusion or breastfeeding women), L.1121-6 (persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care), and L.1121.8 (adults under legal protection or unable to express their consent) of the CSP (French Public Health Code).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT06714851
Study Brief:
Protocol Section:
NCT06714851