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The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs

NCT ID: NCT01800487

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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Hepatitis is one of the most common adverse effect from anti-tuberculosis. Silymarin showed its efficacy to decreased serum alanine transaminase enzyme in animal models from recent study. No confirmed this efficacy was performed in human.

A prospective, double-blind, placebo-controlled trial was carried out according to Good Clinical Practice Guideline. This study is to define the efficacy of silymarin to prevent hepatotoxicity from anti-tuberculosis drugs. Informed consent is obtained prior to the study. New patients diagnosed with tuberculosis are enrolled. Patients with liver diseases, current alcohol drinking more than 20 g/day, regular use of herbal or other potential hepatotoxic drugs are excluded. Patients are treated with a standard regimen of four anti-tuberculosis therapy. They will randomize to receive either placebo or silymarin (140 mg) thrice daily. Liver function test (LFT) and clinical changes are assessed at 2- and 4-week after initiation of the treatment. DILI from anti-tuberculosis drugs ('atb-DILI') is defined as: i) a rise of alanine aminotransferase (ALT) to 2 times above normal upper limit, or ii) an elevation of total bilirubin more than 2 mg/dl with or without ALT elevation. The study endpoints are the level of ALT by week 4 and the number of patients who developed atb-DILI.

Statistical analysis is used to compare the differences in ALT and number of atb-DILI

Detailed Description

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\- Prevention of antituberculosis-related drug induced liver injury with silymarin is investigated.

Conditions

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Tuberculosis

Keywords

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Drug-induced liver injury Tuberculosis Silymarin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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silymarin

Silymarin 140 mg three times a day for 4 weeks

Group Type ACTIVE_COMPARATOR

silymarin

Intervention Type DRUG

140 mg three times a day for 4 weeks

placebo

Placeo

1 tab three times a day for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (silymarin) 1 tab three times a day for 4 weeks

Interventions

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silymarin

140 mg three times a day for 4 weeks

Intervention Type DRUG

Placebo

Placebo (silymarin) 1 tab three times a day for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* tuberculosis cases
* treated with isoniazid, rifampicin, ethambutol and pyrazinamide

Exclusion Criteria

* no known liver disease (HBV, HCV), and HIV infection
* normal ALT level before enrollment
* refuse to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Abhasnee Sobhonslidsuk

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abhasnee Sobhonslidsuk, MD

Role: STUDY_DIRECTOR

Ramathibodi Hospital

Chote Luangchosiri, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi

Locations

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Gastroenterology and Hepatology, Ramathibodi hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Luangchosiri C, Thakkinstian A, Chitphuk S, Stitchantrakul W, Petraksa S, Sobhonslidsuk A. A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury. BMC Complement Altern Med. 2015 Sep 23;15:334. doi: 10.1186/s12906-015-0861-7.

Reference Type DERIVED
PMID: 26400476 (View on PubMed)

Other Identifiers

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Ramathibodi_silymarin

Identifier Type: -

Identifier Source: org_study_id