CTRI/2021/09/036364Not yet recruitingPhase 2
Clinical Evaluation of Gokshuradi Guggulu and Nimbadi Churna in Vatarakta (Gout)
Central Council for Research in Ayurvedic Sciences CCRAS0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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.
Investigators
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