Abexol and Atorvastatin in the non alcoholic steatohepatitis

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

A/A-01

Scientific title:

Comparative study of the effects of Abexol and the Atorvastin in the non alcoholic steatohepatitis

Acronym of Scientific Title:

Abe/Atorva-01

Secondary indentifying numbers:

Abe/Atorva-01

Issuing authority of the secondary identifying numbers:

Center of Natural Products, National Center for Scientific Research

Source(s) of monetary or material support:

Central National Center for Scientific Research Account for BioCubaFarma

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Caridad

Last name:

Ruenes Domech

Medical Specialty :

1er Degree Specialist in Gastroenterology, General Medical Specialist

Affiliation:

Gastroenterology Institute

Postal address:

25 y J, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78329042

Email address:

caridad.ruenes@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Gastroenterology Institute, September 26, 2016

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/01/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Non-Alcoholic Steatohepatitis (NASH)

Health condition(s) code:

Non-alcoholic Fatty Liver Disease

Fatty Liver

Liver Diseases

Digestive System Diseases

Intervention(s):

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 tablet /10 mg), by oral route, at breakfast and dinner time, during 24 weeks Group 3 (Experimental): An Abexol tablet (50 mg) + an Atorvastatin tablet (10 mg), by oral route, at breakfast and dinner time, during 24 weeks Group 4 (Control): A Placebo Abexol tablet + a Placebo Atorvastatin tablet, by oral route, at breakfast and dinner time, during 24 weeks

Intervention code:

Atorvastatin Calcium

Dietary Supplements

Tablets

Placebo

Administration, Oral

Intervention keyword:

Abexol, purified extract of beeswax

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

70 years

Inclusion criteria:

1- Patients with confirmatory biopsy of non alcoholic steatohepatitis

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

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

4

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Center of natural Products, National Center for Scientific Research

Postal Address:

198/19 and 21, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+5372085834

Email :

julio.fernandez@cnic.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Sarahi

Last Name:

Mendoza Castaño

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Center of natural Products, National Center for Scientific Research

Postal Address:

198/19 and 21, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+5372711654

Email :

sarahi.mendoza@cnic.edu.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000221

Date of Registration in Primary Registry:

28/11/2016

Record Verification Date:

2016/11/28

Next update date:

2017/11/28

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

Abexol and Atorvastatin in the non alcoholic steatohepatitis

Acerca del RPCEC

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