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Effects of thebu leaves on fatty liver - phase 2 clinical trial

Phase II clinical trial - the effects of extract of Costus speciosus (thebu) on hepatic insulin resistance and biochemical profile of patients with nonalcoholic fatty liver disease.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2015/019
Enrollment
Unknown
Registered
2015-09-15
Start date
2015-10-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Non-alcoholic fatty liver disease

Interventions

The study will be carried out at the Department of Pharmacology Faculty of Medicine University of Ruhuna with ultra sound scanning done at Teaching Hospital Karapitiya. Consenting participants meetin

Sponsors

Faculty of Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 30-65 years 2. Diagnosis of NAFLD stage 1 and 2 by ultrasound scan by a physician and radiologist

Exclusion criteria

Exclusion criteria: 1. Alcoholism.(consumption of any alcohol within the past 6 weeks) 2. Current treatment with hepatotoxic drugs. 3. Hepatitis B infection (positive HBsAg with recent vaccination) 4. Diabetes mellitus, heart failure, ischaemic heart disease 5. Autoimmune disorders. 6. Any type of long term drug treatment for diabetes, dyslipidemia or high blood pressure.

Design outcomes

Primary

MeasureTime frame
1. 30% reduction in insulin resistence (IR) calculated by using HOMA QUICKI and McAuley indices 2. Sustained reduction in Alanine aminotransferase(ALT) defined as 50% or less of the baseline level or 40U/L or less at clinic visits every 4 weeks. [At baseline, then every 4 weeks for a total of 12 weeks. ]

Secondary

MeasureTime frame
1. Grading of NAFLD on ultra sound scan 2. Health related quality of life.(QOL) 3. Anthropometric variables [At baseline, then every 4 weeks for a total of 12 weeks.]

Countries

Sri Lanka

Contacts

Public ContactProf Menik Hettihewa

Professor of Pharmacology

hettihewamenik@gmail.com0094 91 2234801 or 0094 91 22248677

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026