Health Condition 1: null- Osteoarthritis
Conditions
Interventions
Intervention1: Flexsure Capsules: Ingredients:
Uncaria tomentosa
Boswellia serrata
Lepidium meyenii
L-Leucine
Dosage:
3 capsules to be consumed empty stomach once a day for 56 days
Control Intervent
Sponsors
Vital gNetics
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed of OA of the knee according to the ACR clinical and radiographic criteria. 2.ARA functional class II or III. 3.Kellgren Lawrence radiological severity of Grade II, Grade III OA knee. 4.Maximal OA pain on movement, as measured on a 0-100 Visual analog scale (VAS) should be 40 80 in the previous 24 hrs at screening and baseline visits.
Exclusion criteria
Exclusion criteria: 1.Conditions that can mimic OA knee pain, E.g. rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease 2.BMI 35 kg/m2 3.Indication of surgery for OA knee 4.Arthroscopy of either knee in the past year 5.Use of analgesics or any other symptom-relieving medication within 7 days of screening 6.Use of systemic steroids or herbal medication for OA within 4 weeks of screening 7.Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months 8.Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months 9.History of osteoporotic/ osteoarthritic fractures within the past 6 months 10.Pregnant or lactating women or women with inadequate contraceptive measures 11.Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction) 12.Presence of any clinically significant laboratory anomaly 13.Known cases of AIDS (HIV positive) 14.History of Coronary Angioplasty/CABG within the past 2 years 15.Moderate to severe peripheral neuropathy or other neurological disorders 16.Alcohol abuse, medication or drug dependence 17.Concurrent or previous participation in a clinical study within previous 6 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Flexsure as compared to placebo in reducing symptoms of osteoarthritis (OA) of the knee, using WOMACTimepoint: WOMAC Questionnaire - Day 0, Day 7, Day 14, Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the onset of pain relief with Flexsure as compared to placebo - To assess the safety and tolerability of Flexsure as compared to placeboTimepoint: Day 0, Day 7, Day 14, Day 28 and Day 56 | — |
Countries
India
Contacts
Public ContactDr Bhakti Shinde
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed