Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000621011
Ethics application status
Approved
Date submitted
14/07/2010
Date registered
29/07/2010
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of silymarin in prevention of adverse effects of anti tuberculosis drugs.
Scientific title
Evaluation of Silymarin in prevention of anti tuberculosis drug induced hepatitis in patients newly diagnosed with tuberculosis.
Secondary ID [1] 252241 0
"Nil"
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 257745 0
Drug induced hepatitis 257746 0
Condition category
Condition code
Infection 257919 257919 0 0
Other infectious diseases
Oral and Gastrointestinal 257920 257920 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Silymarin 420 mg per day, for the first 2 weeks of anti-tuberculosis treatment, as oral tablets
Intervention code [1] 256810 0
Prevention
Intervention code [2] 256822 0
Treatment: Drugs
Comparator / control treatment
Placebo, Lactose 420 mg per day, for the first 2 weeks of anti-tuberculosis treatment, as oral tablets
Control group
Placebo

Outcomes
Primary outcome [1] 258783 0
Incidence of drug induced hepatitis,
Drug induced hepatitis means 3 times elevation of liver enzymes with clinical symptoms or 5 times without symptoms. / measurement of liver enzymes
Timepoint [1] 258783 0
First two weeks of treatment initiation trice per week day 2, 4, 6, 9, 11, 14
Secondary outcome [1] 264845 0
Incidence of silymarin adverse effects i. e. nausea, vomiting, bloating, diarrhea, itching by patient questionnaires and daily checklist.
Timepoint [1] 264845 0
Continuously first two weeks of treatment initiation

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. Abnormal liver function tests in the base
5. Patients treated with the regimens other than Isoniazide, Rifampin, Pyrazinamide.

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
9/11/2010
Date of last data collection
Anticipated
Actual
5/02/2011
Sample size
Target
60
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 2766 0
Iran, Islamic Republic Of
State/province [1] 2766 0
Tehran

Funding & Sponsors
Funding source category [1] 257286 0
University
Name [1] 257286 0
Shahid Beheshti medical university
Country [1] 257286 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] 256532 0
Hospital
Name [1] 256532 0
Masih Daneshvari Hospital
Address [1] 256532 0
Dar Abad street, Niavaran, Tehran, post code: 1955841452
Country [1] 256532 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296814 0
NRITLD reseaarch ethihs committee
Ethics committee address [1] 296814 0
NRITLD, Dar Abad, Niavaran, Tehran.
Ethics committee country [1] 296814 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 296814 0
13/07/2009
Approval date [1] 296814 0
14/07/2009
Ethics approval number [1] 296814 0
p/25/29/50438

Summary
Brief summary
One of most important adverse effects of anti tuberculosis drugs is drug induced hepatitis. Adverse effects of drugs are one of causes for treatment interruption. Purpose of this study is prevention or decreasing incidence of drug induced hepatitis.
Trial website
Trial related presentations / publications
Iran J Pharm Res. 2016 Winter;15(1):247-52.
Evaluation of Hepatoprotective Effect of Silymarin Among Under Treatment Tuberculosis Patients: A Randomized Clinical Trial.
Marjani M1, Baghaei P1, Kazempour Dizaji M2, Gorji Bayani P1, Fahimi F3, Tabarsi P1, Velayati AA2.
Author information
Abstract

Hepatic toxicity is the most serious adverse effect of anti-tuberculosis drugs. This study was performed to evaluate the efficacy of silymarin as a hepatoprotective herbal agent. In a randomized double blind clinical trial, 70 new cases of pulmonary tuberculosis were divided into two groups. The intervention group was assigned to receive silymarin and the control group received placebo. Tuberculosis was treated by classic regimen consisting isoniazid, rifampin, pyrazinamide and ethambutol. No statistically significant difference was found between the two groups concerning the frequency of drug induced liver injury or mild elevation of liver enzymes. Silymarin was safe without any major side effect. Our results showed no significant hepatoprotective effect of silymarin among patients on tuberculosis treatment.

Full text of article is available in: http://ijpr.sbmu.ac.ir/article_1825.html
Public notes

Contacts
Principal investigator
Name 31397 0
Dr Majid Marjani
Address 31397 0
Masih Daneshvari Hospital,Dar Abad, Niavaran, Tehran, Postal code: 19569-44413
Country 31397 0
Iran, Islamic Republic Of
Phone 31397 0
+982126109590
Fax 31397 0
Email 31397 0
[email protected]
Contact person for public queries
Name 14644 0
Majid Marjani
Address 14644 0
National Institute of Tuberculosis and Lung Disease, Masih Daneshvari Hospital, Dar Abad street, Niavaran, Tehran, post code:1955841452
Country 14644 0
Iran, Islamic Republic Of
Phone 14644 0
+982126109590
Fax 14644 0
+982126109590
Email 14644 0
[email protected]
Contact person for scientific queries
Name 5572 0
Majid marjani
Address 5572 0
National Institute of Tuberculosis and Lung Disease, Masih Daneshvari Hospital, Dar Abad street, Niavaran, Tehran, post code:1955841452
Country 5572 0
Iran, Islamic Republic Of
Phone 5572 0
+982126109590
Fax 5572 0
+982126109590
Email 5572 0
[email protected]

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 hepatoprotective effect of silymarin among under treatment tuberculosis patients: A randomized clinical trial.2016
N.B. These documents automatically identified may not have been verified by the study sponsor.