Health Condition 1: null- Clinical trial will be conducted on Gout Patients fulfilling the Inclusion criteria
Conditions
Interventions
Intervention1: Amrita Guggulu, Pinda Taila: 1 gm BD with luke warm water and 10 ml for local application at the site of pain. The duration of the treatment is 12 weeks with followup after 2 weeks mont
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 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: i. More than one attack of acute arthritis. ii. Maximal Inflammation developing within 1 day of onset. iii. Monoarthritis attack. iv. Redness over effected joint. v. Unilateral attack on the first Metatarsophalangeal (Big Toe) joint. vi. Unilateral attack involving Tarsal joint. vii. First Metatarsophalangeal (Big Toe) joint, painful or swollen. viii. Suspected Tophi. ix. Hyperuricemia (more than 7.0 mg per dl) x. Asymmetrical swelling within joint (X Ray). xi. Sub cortical cysts without erosions (X Ray). xii. Negative culture from joint fluid during attack. 3. Willing and able to participate in the study for 14 weeks
Exclusion criteria
Exclusion criteria: i. History of any trauma or fractured joint or surgical or diagnostic intervention with reference to the affected joint (s). ii. Patients with comorbidities such as Rheumatoid arthritis Psoriatic arthritis etc. iii. Patients with poorly controlled Hypertension ( > 160/100 mm of Hg). iv. Patients with poorly controlled Diabetes Mellitus (HbA 1c more than 8.0 percent) v. Patients with evidence of malignancy. vi. Patients with unstable cardiovascular disease. vii. Known cases of Hypothyroidism or hyperthyroidism. viii. Patients with any concurrent hepatic disorder (defined as liver enzymes SGOT or SGPT more than 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine more than 1.4 mg per dl) or Severe COPD. ix. Alcoholics/drug abusers. x. History of hypersensitivity to any of the trial drugs or their ingredients. xi. Pregnant or lactating woman. xii. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage decrease in Serum Uric Acid levels from the base line to the end of study period.Timepoint: 12 weeks regimen and followup for 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in SF-36 Health Survey score, Patients Global Assessment, Physicians global Assessment, pain VAS scale. To assess the safety of the trial drug by lab parameters and observing any occurrence of any ADR or AE.Timepoint: 12 weeks regimen and followup for 2 weeks | — |
Countries
India
Contacts
Public ContactDr Rajesh Sannd
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed