Status:
COMPLETED
To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
The current study is designed to assess the pain relieving effect of 4-weeks ingestion of this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per day) in mild to mo...
Detailed Description
This study has been planned to evaluate the efficacy of Lanconone® in enhancing the overall joint health in the population of ≥ 40 years of age during the daily life activities by the reduction of the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03262805
Start Date
August 28 2017
End Date
January 30 2018
Last Update
April 30 2018
Active Locations (3)
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1
Ayush Nursing Home
Mumbai, Maharashtra, India, 400067
2
Kewalramani's Clinic
Mumbai, Maharashtra, India, 400068
3
KK Medical Centre
Mumbai, Maharashtra, India, 400068