Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050758

Enrollment

Registered

2023-03-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M109- Gout, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: With the data of serum uric acid level more than 8.0 mg/dl

Exclusion criteria

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;

Design outcomes

Primary

Measure	Time frame
•The change in serum mean uric acid after 8 weeks of therapy when compared to baselineTimepoint: 0, 4 weeks, 8 weeks	—

Secondary

Measure	Time frame
Change in liver & renal function parameters in blood Timepoint: 0, 4 weeks, 8 weeks;Change in VAS score Timepoint: 0, 4 weeks, 8 weeks;Changes in hemogram (Hb, TLC, DLC)Timepoint: 0, 4 weeks, 8 weeks	—

Countries

India

Contacts

Public ContactDebasish Hota

All India Institute of Medical Sciences Bhubaneswar

pharm_debasish@aiimsbhubaneswar.edu.in9438884190

Outcome results