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Trial record 52 of 582 for:    bilirubin AND liver function

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

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ClinicalTrials.gov Identifier: NCT01800487
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Abhasnee Sobhonslidsuk, Ramathibodi Hospital

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Tuberculosis Drug: silymarin Drug: Placebo Not Applicable

Detailed Description:
- Prevention of antituberculosis-related drug induced liver injury with silymarin is investigated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Silymarin

Arm Intervention/treatment
Active Comparator: silymarin
Silymarin 140 mg three times a day for 4 weeks
Drug: silymarin
140 mg three times a day for 4 weeks

Placebo Comparator: placebo

Placeo

1 tab three times a day for 4 weeks

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




Primary Outcome Measures :
  1. The number of patients who develop drug-induced liver injury (DILI) at 4 weeks [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800487


Locations
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Thailand
Gastroenterology and Hepatology, Ramathibodi hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Investigators
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Study Director: Abhasnee Sobhonslidsuk, MD Ramathibodi Hospital
Principal Investigator: Chote Luangchosiri, MD Ramathibodi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abhasnee Sobhonslidsuk, Associate professor, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01800487     History of Changes
Other Study ID Numbers: Ramathibodi_silymarin
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Abhasnee Sobhonslidsuk, Ramathibodi Hospital:
Drug-induced liver injury
Tuberculosis
Silymarin

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Silymarin
Antitubercular Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents