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Evaluation of Terminalia bellerica in preventing the progression of chronic kidney disease in patients with hyperuricemia.

Evaluation of Terminalia bellerica versus Febuxostat in preventing the progression of chronic kidney disease in patients with hyperuricemia - randomized double blind parallel group study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022093
Enrollment
60
Registered
2019-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention1: Terminalia bellerica 2000mg/day: 2 capsules of 500 mg given orally twice a day after food (total dose of 2000mg/day Terminalia bellerica) Intervention2: Terminalia bellerica 1000mg/day:

Sponsors

Dr K Niranjan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Either gender, between the ages of 18 and 69 years. 2.Serum uric acid level >= 6.0 mg/dL and 3.Serum creatinine >=1.5mg/dl to 4. Ability to comply with the requirements of the study and to give voluntary, written informed consent and willing to come for regular follow up visits.

Exclusion criteria

Exclusion criteria: 1.Presence of a gout flare during screening or baseline visit. 2.Patients currently using aspirin or other NSAIDS, diuretics, steroids, immunosuppressants, other medications with known urate-lowering effects. 3.History or presence of nephrolithiasis. 4.Patients who had undergone renal transplantation. 5.Known liver, thyroid or infectious diseases. 6.Uncontrolled hypertension or diabetes, severe hepatic impairment. 7.Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant). 8.Chronic alcoholics and patients with history or suspicion of drug abuse. 9.Known hypersensitivity to any drugs or their constituents. 10.Pregnant or lactating females. 11.Patients currently on alternative system of medicine. 12.Participation within 30 days prior to screening in another investigational

Design outcomes

Primary

MeasureTime frame
1.Absolute change in serum creatinine and eGFR levels from baseline to the end of 24 weeks of treatment. 2.Mean percentage reduction in serum creatinine and eGFR levels from baseline to the end of 24 weeks of treatment. Timepoint: 0, 4, 8, 12, 16, 20, 24 weeks

Secondary

MeasureTime frame
1.Absolute change in serum uric acid levels from baseline to the end of 24 weeks of treatment. 2.Mean percentage reduction in serum uric acid levels from baseline to the end of 24 weeks of treatment. Timepoint: 0, 4, 8, 12, 16, 20, 24 weeks

Countries

India

Contacts

Public ContactDr P USHARANI

NIZAMS INSTITUTE OF MEDICAL SCIENCES

ushapingali@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 25, 2026