Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
None listed
Sponsors
HEALTHYLIFE INNOV ATION PVT. LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 30-60, from both sexes. 2. Primary complaint of Knee pain- Unilateral or Bilateral, accompanied with Joint Space Narrowing OR cartilage loss and other associated symptoms. 3. Grade 3 and Grade 4 on Kellgren Lawrence OA classification. 4. Chronic knee pain- lasting for more than 3 months with Joint space narrowing at atleast one knee joint either medial/ lateral or both. 5. Willing to complete all study procedures including study-related questionnaires and comply with study requirements. 6. Willing to abstain from other supplements or medication. 7. Ready to give voluntary, written, informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Acute Knee pain due to Traumatic injury with fracture or ligament tear. 2. Persons diagnosed with Rheumatic arthritis, Polyarteritis Nodosa, Gout, Fibromyalgia, Scleroderma. 3. Persons with diagnosed auto-immune disorders. 4. Persons with BMI greater than 34.9. 5. Persons diagnosed with AIDS, Hepatitis B, patients on ART. 6. Persons with known congenital joint disorders. 7. Persons who are diagnosed with Pulmonary or extra pulmonary Tuberculosis, pleural effusion, COPD, Bronchial asthma, or severely compromised lung function. 8. Diagnosed with Hansen s disease or any other infectious disease that needs immediate and long-duration treatment. 9. Bedridden patients. 10. Persons who have undergone knee joint surgery/ hip joint surgery previously. 11. Persons diagnosed with Parkinsonism, Alzheimer s or any other neuro-degenerative disease. 12. Persons with Congestive Heart Disease, Ischemic heart disease and on regular antiplatelet therapy for cardiac disorders. 13. Persons with IBD (Irritable Bowel Disease) /IBS. 14. Persons under regular treatment with medication like Corticosteroids, immunosuppressants, NSAIDS, for medical conditions other than knee pain. 15. Uncontrolled Hypertension or Grade 2 Hypertension: Persons on BP medication yet having Systolic Blood Pressure- above 160 mm of Hg or Diastolic Blood Pressure above 100 mm of Hg. 16. Diabetes 17. Thyroid 18. Pregnant or Lactating mothers. 19. Persons with cholelithiasis, IBD obstruction. 20. Persons diagnosed with solid tumour or malignancy/ under treatment for any type of Cancer or any life-limiting condition, 21. Persons unable to take oral medication due to any physical condition. 22. Compromised Kidney function, Renal calculi, CKD, Renal Failure. 23. Extremely elevated Liver enzymes, any other biologic assessment measure which the investigator deems unfit for the study. 24. Persons with altered cognizance, mentally unfit patients/ unable to give consent. 25. Persons with any reported allergy or intolerance to any ingredient in the study products. 26. Persons deemed unsuitable for study based upon study physician assessment. 27. Persons who have been a part of another clinical trial in the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the change in minimum joint space width (minJSW) in the most narrowed tibiofemoral compartment in persons with knee pain and joint space narrowing using standardized weight-bearing knee radiographs. 2. To assess, using MRI, the compartment-wise change from baseline in mean tibiofemoral articular cartilage thickness (mm) and mean meniscal thickness (mm), as well as change from baseline in articular cartilage volume and meniscal volume.Timepoint: 105 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the impact of the ATPOA of knee on Pain using assessment of VAS. 2. To assess the impact of ATPOA of knee on functionality of the knee joint using WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index) scale.Timepoint: Day 0, 30, 60, & 90. | — |
Countries
India
Contacts
Public ContactDr Santosh Kumar Bhatted
All India Institute of Ayurveda
Outcome results
None listed