Health Condition 1: null- PAIN AND STIFFNESS OF THE KNEE JOINTS
Conditions
Interventions
Intervention1: RASNADI GUTIKA: RASNADI GUTIKA:AFI PART III 5:1
01 GRAM TWICE DAILY ORALLY FOR 84 DAYS
Intervention2: CHANDRAKALA LEPA: CHANDRAKALA LEPA:AFI PART III 9:8
10 ml twice daily locally for 84 days
Intervention3: NIL: NIL
Intervention4: RASNADI GUTIKA AN
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES JANAKPURI NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients of either sex aged between 40 and 75 years. 2) Patient with primary osteoarthritis Knee joint(s) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology; i.e. Knee pain and; At least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch 3) Pain in the affected Knee joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale) i.e. Grade 1: Narrowing is defined as doubtful narrowing of joint space and possible osteophytic lipping. Grade 2: Osteophytes and definite narrowing of joint space. Grade 3: Moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone ends. 4) Willing and able to participate in the study for 03 months.
Exclusion criteria
Exclusion criteria: 1. Patients with Grade IV Kellgren & Lawrence Radiological scale i.e. Grade 4: Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour. 2. History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s). 3. Gross disability in performing daily normal routine i.e. bed ridden patients or confined to a wheelchair. 4. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis. 5. Patients having any deformity of knee hip or back altering the gait and posture of the patient. 6. Patients with Unstable cardiovascular diseases. 7. Patients with uncontrolled diabetes mellitus {HbA1c >6.5%}. 8. Patients with evidence of malignancy. 9. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 10. Patients with any severe renal or hepatic or any other disorder which may interfere in the study. 11. Pregnant / lactating woman. 12. Patients who have participated in other clinical trials within two months of duration. 13. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in WOMAC total score(CRD, Pune version) (At the time of baseline and at the end of the treatment).Timepoint: Total Study Period 24 months Preparatory Period 3 months Recruitment 18 months Treatment Period 3 months Statistical Analysis 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in WOMAC stiffness Domain Score â?¢ Change in WOMAC Physical function Domain . â?¢ Change in WHO QOL BREF Scale (At the time of baseline and at the end of the treatment). â?¢ Assessment of change in the Clinical Parameters (On 0, 14th, 28th, 42nd, 56th, 70th and 84th day). â?¢ Changes in analgesic burden in comparison to baseline (No. of times of use of conventional analgesic drug). [Time frame: at baseline and end of the treatment]. Timepoint: Total Study Period 24 months Preparatory Period 3 months Recruitment 18 months Treatment Period 3 months Statistical Analysis 3 months | — |
Countries
India
Contacts
Public ContactBANAMALI DAS
NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT
Outcome results
None listed