Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000643077
Ethics application status
Approved
Date submitted
4/08/2010
Date registered
9/08/2010
Date last updated
8/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of silymarin in treatment of adverse effects of anti tuberculosis drugs.
Scientific title
Evaluation of Silymarin in treatment of anti tuberculosis drug induced hepatitis in patients newly diagnosed with tuberculosis.
Secondary ID [1] 252357 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 257866 0
Condition category
Condition code
Infection 258030 258030 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Silymarin 420 mg per day,in three doses, It will start after diagnosis of drug induced hepatitis and stop after normalization of liver function tests, as oral tablets
Intervention code [1] 256934 0
Treatment: Drugs
Comparator / control treatment
Lactose 420 mg per day,in three doses, It will start after diagnosis of drug induced hepatitis and stop after normalization of liver function tests, as oral tablets
Control group
Placebo

Outcomes
Primary outcome [1] 258894 0
Normalization of liver function tests
Timepoint [1] 258894 0
Evaluation of liver function tests three times weekly from diagnosis of drug induced hepatitis (Drug induced hepatitis means 3 times elevation of liver enzymes with clinical symptoms or 5 times without symptoms.)until normalization of them.
Secondary outcome [1] 265051 0
Incidence of silymarin adverse effects i. e. nausea, vomiting, bloating, diarrhea, itching by patient questionnaires and daily checklist.
Timepoint [1] 265051 0
Continuously during administration of drug/placebo

Eligibility
Key inclusion criteria
New cases of tuberculosis
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infection with Human Immune deficiency virus 2. Infection with hepatitis B virus 3. Infection with hepatitis c virus 4.pregnancy 5. Breast feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2757 0
Iran, Islamic Republic Of
State/province [1] 2757 0
Tehran

Funding & Sponsors
Funding source category [1] 257383 0
University
Name [1] 257383 0
Shahid Beheshti medical university
Country [1] 257383 0
Iran, Islamic Republic Of
Funding source category [2] 257384 0
University
Name [2] 257384 0
Shahid Beheshti medical university
Country [2] 257384 0
Iran, Islamic Republic Of
Funding source category [3] 257385 0
University
Name [3] 257385 0
Shahid Beheshti medical university
Country [3] 257385 0
Iran, Islamic Republic Of
Primary sponsor type
Government body
Name
National Institute of Tuberculosis and Lung Disease (NRITLD)
Address
Dar Abad street, Niavaran, Tehran, post code: 1955841452
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256623 0
Hospital
Name [1] 256623 0
Masih Daneshvari Hospital
Address [1] 256623 0
Dar Abad street, Niavaran, Tehran, post code: 1955841452
Country [1] 256623 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Adverse effects of antituberculosis drugs are frequent, sometimes with morbidity and even may be fatal, most serious of them is drug induced hepatitis.
As Sylimarin in rat model has been effective in prevention and treatment of hepatic adverse effects of anti tuberculosis drugs, we decide to investigate this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31384 0
Dr Majid Marjani
Address 31384 0
Masih Daneshvari Hospital, Dar Abad, Niavaran, Tehran
Post code: 1956944413
Country 31384 0
Iran, Islamic Republic Of
Phone 31384 0
+982126109590
Fax 31384 0
Email 31384 0
marjani216@hotmail.com
Contact person for public queries
Name 14631 0
Dr Majid Marjani
Address 14631 0
National Institute of Tuberculosis and Lung Disease, Masih Daneshvari Hospital, Dar Abad street, Niavaran, Tehran, post code:1955841452
Country 14631 0
Iran, Islamic Republic Of
Phone 14631 0
+982126109590
Fax 14631 0
Email 14631 0
marjani216@hotmail.com
Contact person for scientific queries
Name 5559 0
Dr Majid Majani
Address 5559 0
National Institute of Tuberculosis and Lung Disease, Masih Daneshvari Hospital, Dar Abad street, Niavaran, Tehran, post code:1955841452
Country 5559 0
Iran, Islamic Republic Of
Phone 5559 0
+982126109590
Fax 5559 0
Email 5559 0
marjani216@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of Silymarin for management of anti-tuberculosis drug induced liver injury: A randomized clinical trial.2019https://dx.doi.org/10.22037/ghfbb.v12i2.1562
N.B. These documents automatically identified may not have been verified by the study sponsor.