Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Polyherbal Formulation
INDR/OA/001: INDR/OA.001 is a nutraceutical, polyherbal formulation intended for treatment of osteoarthritis.
Dosage : 2 capsules, twice a day for 3 months
Contro
Sponsors
AVN Ayurveda Formulation Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults between 30 and 60 years of age with confirmed diagnosis or known history of osteoarthritis with moderately active lifestyle (both sexes and ages inclusive) 2. Subject with Grade II or III of Kellergen Lawrence (KL) Grade. 3. Subject with pain (Pain Scale score is 4) on walking in one or both knees 24 hours prior to screening. 4. Subjects with BMI is less than or equal to 30 at the time of screening. 5. Subjects who are ambulatory, requiring but not currently receiving or not satisfied with anti-inflammatory or anti-analgesic drugs 6. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period. 7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to herbal investigational product or its constituents. 2. Subjects with known hypersensitivity to NSAID, aspirin, COX-2 inhibitors and other analgesic medicine. 3. Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment. 4. Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment. 5. Subjects with immunucompromised state complications. 6. Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability. 7. Concomitant inflammatory or any other disease/condition which may affect joints (eg, rheumatoid arthritis, metabolic bone disease,psoriasis, gout, pseudogout, chondrocalcinosis etc.). 8. History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint. 9. History of surgery in the target joint. 10. Planned surgery on any lower extremity joint. 11. Clinically significant venous or lymphatic stasis present in the leg(s). 12. Clinically apparent tense effusion or inflammation at the target knee. 13. Any musculoskeletal condition that would impede measurement of efficacy at the target joint 14. Subjects with uncontrolled diabetes, hypertension or congestive heart failure. 15. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g.,planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 16. Females who are pregnant or lactating or planning to become pregnant during the study period. 17. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 18. Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. WOMAC Scale: Reduction by 20 scores 2. Pain Scale: Reduction by 4 scores 3. Quality of life Questionnaire: Improvement by 10 scores 4. Objective Assessment: Physicianâ??s Impression of Change Scale: Score of 2 or 1. Timepoint: 1. WOMAC Scale: Day0, Day 30, Day 60, Day 90, Day 97, Day 104, Day 111, Day 118. 2. Pain Scale: Day0, Day 30, Day 60, Day 90, Day 97, Day 104, Day 111, Day 118. 3. Quality of Life Questionnaire: Day0, Day 30, Day 60, Day 90, Day 97, Day 104, Day 111, Day 118. 4. Physicians Global Impression of Change: Day 30, Day 60, Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. WOMAC Scale: Reduction by 10 scores 2. Pain Scale: Reduction by 2 scores 3. Quality of life Questionnaire: Improvement by 5 scores 4. Objective Assessment: Physicianâ??s Impression of Change Scale: Score of 3 5. Change of Pain and Symptoms: 11-20 percent variation 6. SOS Medication: Dose and Dosage of SOS medication. Timepoint: 1. WOMAC Scale: Day0, Day 30, Day 60, Day 90, Day 97, Day 104, Day 111, Day 118. 2. Pain Scale: Day0, Day 30, Day 60, Day 90, Day 97, Day 104, Day 111, Day 118. 3. Quality of Life Questionnaire: Day0, Day 30, Day 60, Day 90, Day 97, Day 104, Day 111, Day 118. 4. Physicians Global Impression of Change: Day 30, Day 60, Day 90. | — |
Countries
India
Contacts
Public ContactDr VTSriraam
Aurous HealthCare Research and Development India Pvt Ltd
Outcome results
None listed