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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT03262805
Eligibility Criteria:
Inclusion Criteria:
* M/F subject aged ≥ 40 to ≤ 65 with unilateral or bilateral OA of the knee for greater than 3 months as presented by pain in knee.
* Body mass index (BMI) must be 25 to 29.9 kg/m2.
* WOMAC pain score for index joint: 10 to 16.
* Physically active subjects as indicated by day to day involvement in the mentioned physical activity namely:
* Daily walk of 500 to 1000 meters.
* Routine activities such as descending/ ascending stairs, standing up from a chair; bending to floor; travelling by public transport, domestic cleaning etc.
* Climbing 1 or more fleets of stairs.
* Osteoarthritis grade I/ II (Kellgren-Lawrence classification) as confirmed by radiographic evidence.
Exclusion Criteria:
* Subjects with a history of any joint replacement surgery.
* Subjects not willing to abstain from use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health/ local analgesics or other traditional pain relieving therapies such as message or acupuncture etc. during the study duration will be excluded.
* Subject with uncontrolled hypertension (blood pressure: systolic ≥140 mm Hg or diastolic ≥ 100 mm Hg) at screening.
* Subjects with history of thyroid hormone derangement will have to provide a recent (within 3 months) thyroid profile report indicative of euthyroid status.
* Use of any immunosuppressive drugs in the last 12 months.
* Use of any corticosteroids drugs in the last 3 months.
* Subject unwilling to refrain from analgesic measures at least 48 hours before each site visit.
* FBS \>140 mg/dl.
* History of restless leg syndrome.
* Glucocorticoid injection or hyaluronic acid injection in affected joint within 3 months prior to enrolment.
* Subjects with a chronic pain syndrome and in the judgment of the Investigator is unlikely to respond to any therapy.
* Smokers and tobacco users.
* Alcohol consumption of more than 200 ml/ week
* History of surgery in lower limb.
* Subjects suffering from diabetic neuropathy.
* Subjects suffering from deep vein thrombosis.
* Pregnant / lactating women and women who are planning to get pregnant.
* Recent (\< 3 months) participation in a clinical study.
* History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
* Subjects with localized trauma to the lower limb.
* A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms.
* Subjects planning to travel in the next 35 days or engage in any non-routine activity that is likely to strain the knees.
* Subject a history of malignancy, active gastrointestinal disease, chronic or acute renal/hepatic disorders, or significant coagulation disorders.
* Subjects on vitamins, nutritional supplement or herbal product since last 2 weeks.
* Subjects otherwise judged by the investigator to be inappropriate for inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT03262805
Study Brief:
Protocol Section:
NCT03262805