Health Condition 1: M190- Primary osteoarthritis of other joints
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex aged between 25 and 65 years Confirmed cases of Primary Gouty arthritis fulfilling the diagnostic criteria as recommended by the American College of Rheumatology (1977), it should meet the presence of any six of the following twelve criteria: More than one attack of acute arthritis. Maximal Inflammation developing within 1 day of onset. Monoarthritis attack Redness over affected joint Unilateral attack on the first Metatarsophalangeal (Big Toe) joint. Unilateral attack involving Tarsal joint. First Metatarsophalangeal (Big Toe) joint Painful or Swollen. Suspected Tophi Hyperuricemia (>=7.0 mg/dl) Asymmetrical swelling within joint (X Ray) Sub cortical cysts without erosions(X Ray) Negative culture from joint fluid during attack. Willing and able to participate in the study for 14 weeks.
Exclusion criteria
Exclusion criteria: Age less than 25 yrs or more than 65yrs. ii. History of any trauma/ fractured joint/ surgical/diagnostic intervention with reference to the affected joint(s). iii. Patients with co-morbidities such as Rheumatoid arthritis, Psoriatic arthritis etc. iv. Patients with poorly controlled Hypertension ( >160/100 mm of Hg). v. Patients with poorly controlled Diabetes Mellitus (HbA1c > 8.0%) vi. Patients with evidence of malignancy. vii. Patients with unstable cardio-vascular disease. viii. Known cases of Hypothyroidism or hyperthyroidism. ix. Patients with any concurrent hepatic disorder or Renal Disorders (S. Creatinine >1.2 mg/dl) or Severe COPD. x. Alcoholics/drug abusers. xi. H/o hypersensitivity to any of the trial drugs or their ingredients. xii. Pregnant/lactating woman. xiii. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pain assessment on VAS scale Change in Ayurvedic parameters of Vatarakta Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean percentage decrease in Serum Uric Acid levels from the baseline to the end of study period. Improvement in SF-36 Health Survey score Change in Physicianâ??s Global Assessment. Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Poonam Mohod
Regional Ayurveda Research Institute (RARI)
Outcome results
None listed