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Effect of Phyllanthus niruri (Bhumi Amla / keelanelli in tamil) on improving liver functions in patients with liver dysfunction caused by alcohol intake

Efficacy of Phyllanthus niruri on improving liver functions in patients with alcoholic hepatitis: A double blind randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008712
Enrollment
100
Registered
2017-05-31
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: null- Mild to moderate alcoholic hepatitis

Interventions

Intervention1: Phyllanthus niruri: Capsule Phyllanthus niruri 500 mg BD for 4 weeks Control Intervention1: Placebo: Similar looking placebo capsule 500 mg BD for 4 weeks

Sponsors

JIPMER Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Alcoholic hepatitis patients aged 18-65 years with present history of alcohol abuse of either gender as confirmed by CAGE questionnaire score >=2 Patients with abnormal liver function tests with AST/ALT ratio >2

Exclusion criteria

Exclusion criteria: Patients who are terminally ill (encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome) with severe alcoholic hepatitis (Maddreys discriminant function >=32) Patients with viral and drug induced hepatitis Patients with comorbid conditions like coronary artery disease, peripheral vascular disease etc. Pregnant women or lactating mothers; Women in reproductive age group not practicing contraceptive measures Patients who had participated in other trials in the past three months Patients on herbal medications

Design outcomes

Primary

MeasureTime frame
AST, ALT, ALP, bilirubin, albumin, prothrombin time, creatinine, blood urea nitrogen, complete hemogramTimepoint: Baseline, at the end of 2 weeks and 4 weeks

Secondary

MeasureTime frame
Oxidative stress markers (serum malondialdehyde) and anti-oxidant enzymes (reduced glutathione, total oxidant status and total antioxidant status), symptoms and adverse drug reactionsTimepoint: Baeline, at the end of 2 weeks and 4 weeks

Countries

India

Contacts

Public ContactDr Chanaveerappa Bammigatti

JIPMER

gcnx@rediffmail.com9443843946

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026