Pentoxifylline and Metformin versus Placebo for The Treatment of Patients with Nonalcoholic steatohepatitis, A Randomized, Double-Blinded, Placebo- Controlled Clinical Trial.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20130528001

Enrollment

Registered

2013-05-28

Start date

2012-12-01

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

Nonalcoholic steatohepatitis NASH Pentoxifylline Metformin Fibroscan&#8482

Interventions

pentoxifylline 400 mg od plus metformin 500mg od for 4 weeks then pentoxifylline 400 mg bid plus metformin 500mg bid for 4 weeks then pentoxifylline 400 mg tid plus metformin 500mg tid for 40 weeks ,

Experimental Drug,Experimental Drug

pentoxyfylline and metformin treatment,placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. biopsy proven NASH performed within 2 year of entry 2. ALT > 1.5 times of ULN and repeated at least twice over 6 months 3. life style modification in the outpatient clinic for up to 3 months and persistent ALT elevation 4. Not taking metformin or PTX at least 3 month prior to entry 5. type 2 DM Patients included only if on oral hypoglycemic drug and with hemoglobin A1C <8%

Exclusion criteria

Exclusion criteria: 1. Alcohol intake > 20gm/day in men and 10 gm/day in women for 2 years Other chronic liver diseases 2. Decompensated cirrhosis 3. Secondary steatohepatitis e.g. drug (tamoxifen, methotrexate, amiodarone, valproate, glucocorticoid) 4. Taking medications that have shown benefits in previous NASH studies e.g. pioglitazone, Vitamin E, Folic acid, UDCA, Omega 3, NAC Cr > 1.5mg/dl 5. A history of drug allergy to PTX or methylxanthines (caffeine, theophylline) and metformin 6. Risk of bleeding tendency 7. Pregnancy 8. Refuse Liver biopsy

Design outcomes

Primary

Measure	Time frame
Nafld activity score 48 weeks liver biopsy	—

Secondary

Measure	Time frame
liver stiffness 24 weeks and 48 weeks fibroscan,liver fibrosis score 24 weeks and 48 weeks liver fibrosis score,liver enzyme 24 weeks and 48 weeks AST/ALT	—

Contacts

Public ContactSombat Treeprasertsuk

King chulalongkorn memorial hospital

battan5410@gmail.com022564482

Outcome results

None listed

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

Pentoxifylline and Metformin versus Placebo for The Treatment of Patients with Nonalcoholic steatohepatitis&#44; A Randomized&#44; Double&#45;Blinded&#44; Placebo&#45; Controlled Clinical Trial.