Health Condition 1: M17- Osteoarthritis of knee
Conditions
Interventions
Intervention1: Dietary supplement capsules: Dose: One capsule
Route of administration:Oral
Frequency: One capsule in morning
Instruction:
consume one capsule every morning after the breakfast at the s
Sponsors
OmniActive Health Technologies
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and/or female subjects aged between 35 and 75 years (both limits inclusive). 2. Clinical diagnosis of unilateral or bilateral knee osteoarthritis for at least greater than 3 months, as presented by pain in the knee at least for last 3 months. 3. Subject with index knee joint pain rated = 60 on a 100-point Pain-VAS scale. 4. Subject with knee osteoarthritis grade II/III (Kellgren- Lawrence classification). 5. Subjects willing to be involved in regular physical activity such as walking, climbing stairs, recording forms, eating, exercise behaviors, etc. 6. Subjects who are able to walk for at least 6 minutes at a moderate-to-brisk pace on treadmill. 7. Subjects willing to avoid NSAIDs and other antiinflammatory medications during the study period. 8. Subjects who agree to stay weight stable during the study period. 9. Subject able to follow the instruction for Investigational product administration and is 100% compliant with Investigational product during placebo run-in period. 10. Female subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence: Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment. OR Postmenopausal for at least 1 year. OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject). 11. Subjects willing to provide written consent. 12. Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 2. Subjects with positive Urine Pregnancy Test at Screening /Randomization Visit. 3. Subjects with previous history of knee osteoarthritis for more than 3 years. 4. Subjects with previous history of any knee joint replacement surgery. 5. Subjects with severe knee osteoarthritis in Grade 4 as per Kellgren and Lawrence Scale. 6. Subjects unwilling to refrain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health or local analgesics during the study duration. 7. Subjects with history hypothyroidism and have the thyroid deficiency except euthyroid. 8. History of allergy or sensitivity to Curcumin, Boswellia and Ashwagandha, related compounds or any component of the formulation. 9. Subjects with use of any immunosuppressive drugs in the last 12 months (including steroids). 10. Subjects with poorly controlled hypertension. (Systolic Blood Pressure =140 mm Hg and Diastolic Blood Pressure = 90 mm Hg). 11. Subjects with history of uncontrolled diabetes. 12. Subjects with history of restless leg syndrome. 13. Subjects with evidence of malignancy. 14. Use of Glucocorticoid injection or hyaluronic acid injection in the affected joint within 3 months prior to enrolment. 15. Subjects with a chronic pain syndrome and in the judgment of the Investigator is unlikely to respond to any therapy. 16. Subjects with history of significant trauma or surgery in the lower limb. 17. History or presence of active rheumatic disease that may be responsible for secondary knee osteoarthritis. 18. Subjects with history of diabetic neuropathy. 19. Subjects with history of deep vein thrombosis. 20. Subjects with history of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections. 21. Subjects with history of bilateral hip joint replacements. 22. Subjects with current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/dietary supplement. 23. Any condition that, in the opinion of the investigator, renders the subject unable to participate in the study. 24. Subjects who smoke or consume tobacco products. 25. Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry. 26. Subjects who are taking calcium and vitamin D beyond RDA levels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC IndexTimepoint: Day 84 (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC IndexTimepoint: Day 5;joint painTimepoint: Day 5;joint health-Lequesne IndexTimepoint: Day 5;joint pain - VASTimepoint: Day 84 (week 12);enduranceTimepoint: Day 84 (week 12);muscle strengthTimepoint: Day 84 (week 12);joint health by Lequesne IndexTimepoint: Day 84 (week 12);inflammationTimepoint: Day 84 (week 12);serum COMP, Serum CTX-II and serum MMP-3Timepoint: Day 84 (week 12);Quality of Life (QoL)Timepoint: Day 84 (week 12);rescue medicationTimepoint: Day 84 (week 12) | — |
Countries
India
Contacts
Public ContactDr D Sathish Kumar
G7 Synergon Private Limited
Outcome results
None listed