Abexol and Atorvastatin in the non alcoholic steatohepatitis

Comparative study of the effects of Abexol and the Atorvastin in the non alcoholic steatohepatitis - Abe/Atorva-01

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000221

Enrollment

100

Registered

2016-11-28

Start date

2017-01-15

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Interventions

Group 1 (Control): An Abexol tablet (50 mg) + a Placebo Atorvastatin tablet, by oral route, at breakfast and dinner time, during 24 weeks Group 2 (Control): A Placebo Abexol tablet + an Atorvastatin

Atorvastatin Calcium

Dietary Supplements

Tablets

Placebo

Administration, Oral

Abexol, purified extract of beeswax

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1- Patients with confirmatory biopsy of non alcoholic steatohepatitis

Exclusion criteria

Exclusion criteria: 1-Actual consuming of alcohol. 2-Infection by C and B virus. 3-Autoinmune hepatopaties. 4-Hemocromatosis. 5.Hepatoxicity. 6-VIH. 7-Secundary cause of NASH. 8-Pregnant women, women project being pregnant or who are breastfeeding. 9-Uncompensated diabetic patients

Design outcomes

Primary

Measure	Time frame
Histological improvement (Kleiner Index 0-11points). Measuring time: before starting treatment and at the end of the 24 weeks Insulinoreseistence improvement (HOMA2-IR) . Measuring time: before starting treatment and at the end of the 24 weeks	—

Secondary

Measure	Time frame
Insulin secretion (HOMA%B test). Measuring time: at baseline and at the end of 24 weeks Transaminases (GPT (UI/L), GOT (UI)). Measuring time: at baseline and at the end of 24 weeks Lipid profile (Cholesterol (mmol/L), HDL-Cholesterol (mmol/L), Triglycerides (mmol/L)).Measuring time: at baseline and at the end of 24 weeks Anthropometric values (Weight (kg), Body Mass Index (kg/m2), Waist circumference (cm)). Measuring time: at baseline and at the end of 24 weeks. Safety and tolerability: Physical status (Rate (beats/min), blood pressure (mmHg)). Measuring time: at baseline and at the end of 6, 12, 18 and 24 weeks. Blood chemistry parameters (Gamma-Glutamyl Transpeptidase-GGT (U/L), Creatine Kinase-CK (U/L), Glucose (mmol / L), Creatinine (µmol / L), Glycosylated hemoglobin). Measuring time: at baseline and, at the end of 12 and 24 weeks. Adverse events (description-AE name), intensity (mils, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated). Measuring time: at the end of 6, 12, 18 and 24 weeks	—

Measure

Time frame

Insulin secretion (HOMA%B test). Measuring time: at baseline and at the end of 24 weeks Transaminases (GPT (UI/L), GOT (UI)). Measuring time: at baseline and at the end of 24 weeks Lipid profile (Cholesterol (mmol/L), HDL-Cholesterol (mmol/L), Triglycerides (mmol/L)).Measuring time: at baseline and at the end of 24 weeks Anthropometric values (Weight (kg), Body Mass Index (kg/m2), Waist circumference (cm)). Measuring time: at baseline and at the end of 24 weeks. Safety and tolerability: Physical status (Rate (beats/min), blood pressure (mmHg)). Measuring time: at baseline and at the end of 6, 12, 18 and 24 weeks. Blood chemistry parameters (Gamma-Glutamyl Transpeptidase-GGT (U/L), Creatine Kinase-CK (U/L), Glucose (mmol / L), Creatinine (µmol / L), Glycosylated hemoglobin). Measuring time: at baseline and, at the end of 12 and 24 weeks. Adverse events (description-AE name), intensity (mils, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated). Measuring time: at the end of 6, 12, 18 and 24 weeks

—

Countries

Cuba

Contacts

Public ContactJulio Fernandez Travieso

Center of natural Products, National Center for Scientific Research

julio.fernandez@cnic.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026