To evaluate the Safety and efficacy of two Unani formulations in the treatment of Gout
Phase 2
- Conditions
- Health Condition 1: M109- Gout, unspecifiedHealth Condition 2: null- Niqris (Gout)
- Registration Number
- CTRI/2015/03/005610
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
•Patients of either sex in the age group of 18-60.
•Serum uric acid level: normal or above normal
•Patients of gout having any of the following symptoms and signs:
ï?§Joint Pain (especially first metatarsophalangeal (MTP) joint)
ï?§Tenderness
ï?§Swelling
ï?§Redness
Exclusion Criteria
•Other diseases involving small & large joints
•Pregnant and lactating women
•Patients having any systemic diseases such as hypertension, diabetes mellitus, Cardiovascular/Cerebrovascular diseases, hepatic and renal disease, osteomalacia, osteoporosis
•Obesity (BMI: >= 30)
•Patients on long term medications
•Patients taking drugs which increase serum uric acid levels (thiazide diuretics, etc.) and decrease serum calcium levels (furosemide, etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in signs and symptoms of Niqris (Gout)Timepoint: Improvement in signs and symptoms of Niqris (Gout)
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safety assessmentTimepoint: 12 weeks