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Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease

T

Tanta University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Fatty Liver

Treatments

Other: Standard Therapy
Drug: Erdosteine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries (1). NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. NAFLD is characterized by excessive hepatic fat accumulation without other recognized causes of increased fat content (e.g., alcohol, virus, drugs, and autoimmunity). According to the Clinical Practice Guidelines of the European Association for the Study of the Liver, the diagnosis of NAFLD requires the exclusion of daily alcohol consumption >30 g for men and >20 g for women

Enrollment

50 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).

Exclusion criteria

Pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake > 30 g per day in men and > 20 g per day in women).

Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, and autoimmune hepatitis.

Patients suffering from chronic kidney disease, hyper/hypoparathyroidism. Hypersensitivity to erdostiene.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Control group
Active Comparator group
Description:
25 patients received the standard conventional therapy in addition to placebo for 3 months.
Treatment:
Other: Standard Therapy
Erdosteine group
Active Comparator group
Description:
25 patients were given the standard conventional therapy plus erdostiene 300 mg two times daily.
Treatment:
Drug: Erdosteine
Other: Standard Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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