Health Condition 1: null- Osteoarthritis of Knee (Janugata Sandhivata)
Conditions
Interventions
Intervention1: Rasnadi Kvatha (Maha) (AFI – Part I, 4 : 28), Trayodashanga Guggulu (AFI – Part I, 5 : 4) and Brihatsaindhavadya Taila (AFI – Part I, 8 : 40): 1. Rasnadi Kvatha (Maha) (AFI – Part I, 4
Dosage form- (Add 4 times water in 25 gm churna and boil till it is reduced to ¼) on empty stomach
Route of Administration- Orally
Time of Administration- Twice a day in the morning and evening empty stomach
Duration of therapy - 12 weeks.
2. Trayodashanga Guggulu (AFI – Part I, 5 : 4).
Dose- 3 Tablets twice daily
Dosage form- Tablet of 500 mg each
Time of Administration- Twice a day after food
Duration of therapy- 12 weeks.
3. Brihatsaindhavadya Taila (AFI – Part I, 8 : 40).
Dose- 20 ml twice daily
Dosage form- Taila
Route of Administration- Local application
Time of Administration- Twice a day at 12 hrs interval
Duration of therapy- 12 weeks.
Control Intervention1: Rasnadi Kvatha (Maha) (AFI – Part I, 4 : 28), Trayodashanga Guggulu (AFI – Part I, 5 : 4) and Brihatsaindhavadya Taila (AFI – Part I, 8 : 40): 1
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients of either sex aged between 35 and 65 years. 2) Patient with Primary Osteoarthritis (knee joints) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology. (ACR clinical classification criteria) Knee pain and at least three of the following 6 criteria: i. 50 years of age or older ii. Stiffness lasting less than 30 minutes iii. Crepitus iv. bony tenderness v. bony enlargement vi. no warmth to the touch 3) With radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale) Kellgren & Lawrence Radiological scale 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. Grade 4: Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour. 4) Willing and able to participate in the study for 16 weeks.
Exclusion criteria
Exclusion criteria: 1) Patients with Grade IV Kellgren & Lawrence Radiological scale. 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. bedridden 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 uncontrolled hypertension ( >160/100 mm of Hg). 7) Patients with uncontrolled diabetes mellitus HbA1C > 7% 8) Patients with evidence of malignancy. 9) The patient has been administered any chondroprotective drugs, intra-articular injection into the affected joint. 10) 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. 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) 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]). 13) Pregnant / lactating woman. 14) Patients who are currently participating in any other clinical trial. 15) Patients who have completed participation in any other clinical trial during the past six months 16) Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any changes in INDIAN WOMAC (MODIFIED–CRD PUNE VERSION)Timepoint: from base line to end of 4th, 8th, 12th, 16th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in Ayurvedic disease specific symptoms of Sandhivata 2. Assessment Quality of life by using WHOQOL BREF questionnaire 3. Change in the visual analogue scale (VAS) for pain in last 48 hrs 4. Patients and Physicians Global assessment of disease activity 5. Use of no. of NSAID / analgesic medication is recorded 6. Change in WOMAC stiffness domain score 7. Change in WOMAC physical function domain.Timepoint: from base line to end of 4th, 8th, 12th, 16th week | — |
Countries
India
Contacts
Public ContactDr Bhuvnesh Kumar Sharma
M.S. Regional Ayurveda Research Institute for Endocrine Disorders
Outcome results
None listed