classical Ayurvedic Management of Sandi vata(Osteo arthritis of Knee)
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: null- Osteo arthritis of knee joint
- Registration Number
- CTRI/2017/11/010340
- Lead Sponsor
- Ministry of AYUSH Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1.Patients of either sex with age between 35 and 65 years
2.Patients of primary osteoarthritis knee
(Unilateral or bilateral with knee pain >= 14 mm on a 100 mm
visual analogue scale and at least 3 of following ACR clinical
category diagnostic criteria i.e.,
i) Crepitus on active motion
ii) less than 30 min of morning stiffness
iii) Joint tenderness
iv) Joint enlargement
v) No palpable warmth of synovium
3. Radiological changes as per Grade I- Grade III of
KELLGREN LAWRENCE Radiological scale
4.Able and willing to participate and to provide signed informed consent.
1.Patient with Grade IV Kellgren & Lawrence Radiological scale.
2.History of trauma/ fractured joint/ surgical/ diagnostic intervention with reference to the affected joints
3.Patients with co- morbidities such as Gouty Arthritis, Rheumatoid Arthritis and Psoriatic Arthritis.
4.Patients having any deformity of knee, hip or back altering the gait and the posture of the patient.
5.Any unstable cardiovascular disease.
6.Patients who are not ready for IPD admission or for Panchakarma procedures.
7.Patients with ESR level above 35mm/hr
8.Patients with poorly controlled Hypertension ( >160/100 mmHg)
9.Patients with poorly controlled Diabetes Mellitus having HbA1C of > 6.5%
10.Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study.
11.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
12.Symptomatic patient with clinical evidence of Heart failure.
13.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase(ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary
Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
14.The Patient has been administered any chondroprotective drugs, intra articular injections into the affected joints or systemic medications with corticosteroids, during the preceding 3 months
15.Alcoholics and/or drug abusers
16.H/o hypersensitivity to any of the trial drugs or their ingredients
17.Pregnant/lactating woman.
18.Patients who have completed participation in any other clinical trial during the past six months.
19.Other conditions which are contraindicated for prescribed treatments.
20.Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief from Pain and Tenderness, changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total Score. <br/ ><br>Changes in X Ray <br/ ><br>Timepoint: 0 day, 21st day and 45th day <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Changes in WOMAC subscales of pain <br/ ><br>2.Changes in WOMAC subscales of stiffness <br/ ><br>3.Changes in WOMAC subscales of function <br/ ><br>4.Well being of the patient. SF-36 Score <br/ ><br>5.Evaluation of the analgesic burden of the patient will be assessed <br/ ><br>Timepoint: 0day,21st day,45th day and 60th day