Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis
Phase 4
- Conditions
- Health Condition 1: M109- Gout, unspecified
- Registration Number
- CTRI/2023/03/050758
- Lead Sponsor
- Shree Dhanwantri Herbals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
With the data of serum uric acid level more than 8.0 mg/dl
Exclusion Criteria
1. Significant liver or Renal dysfunction, Hematological disease, Oncological disease, or other life threatens disorders.
2.Condition that need the management of diuretics or analgesics agent
3.Severe cerebrovascular disease or severe heart disease;
4.Mental diseases such as schizophrenia, depressive disorder, and drug dependence
5.Alcohol abuse or dependence
6.Aspartate aminotransferase (GOT) or alanine aminotransferase (GPT) level 2 times higher than the normal upper limit;
7.Creatinine higher than 2 mg/dl
8.Pregnant, lactating, or planning to become pregnant within 3 months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •The change in serum mean uric acid after 8 weeks of therapy when compared to baselineTimepoint: 0, 4 weeks, 8 weeks
- Secondary Outcome Measures
Name Time Method Change in liver & renal function parameters in blood <br/ ><br> <br/ ><br>Timepoint: 0, 4 weeks, 8 weeks;Change in VAS score <br/ ><br>Timepoint: 0, 4 weeks, 8 weeks;Changes in hemogram (Hb, TLC, DLC)Timepoint: 0, 4 weeks, 8 weeks