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The evaluation effects of the Livercare tablet (combination of Milk Thistle, Dandelion, Barberry, Tumeric (Curcumin) and Artichoke) in the prevention of anti-tuberculosis drugs-induced hepatotoxicity

Protocol summary

Study aim
The evaluation effects of the Livercare tablet (combination of Milk Thistle, Dandelion, Barberry, Tumeric (Curcumin) and Artichoke) in the prevention of anti-tuberculosis drugs-induced hepatotoxicity
Design
A randomized controlled clinical trial with parallel groups, two blinded, randomized
Settings and conduct
Patients are selected from Al-Zahra Hospital in Isfahan and are not aware of the therapeutic content of the other group, and the researcher does not know the medication packages provided by the pharmacologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 20 to 65 Active pulmonary or extrapulmonary tuberculosis No first-line anti-tuberculosis drugs (isoniazid, rifampin, pyrazinamide) in all patients in the past 8 weeks and starting on treatment No known hepatotoxic drugs (sodium valproate, methotrexate and sulfonamides) No continuous use of acetaminophen No systemic glucocorticoids, supplements containing thistle, dandelion, barberry, turmeric or artichoke in the past 4 weeks Exclusion criteria: Patient dissatisfaction alcohol consumption liver disease Discontinue medication for any reason other than liver toxicity Patient Withdrawal from Study Continuation Not taking the study tablet for at least 3 consecutive days
Intervention groups
For the intervention group, Livercare tablets will be prescribed twice a day for 2 weeks at the same time as the anticonvulsants (isoniazid, rifampin and pyrazinamide). The control group will receive only standard anti-cellulite treatment with placebo. Prior to the administration of the antiplatelet drugs and interventions mentioned above and immediately after the intervention, 5 ml of venous blood was taken from each patient in fasting state to measure liver enzymes and bilirubin.
Main outcome variables
Hepatic Enzymes (AST, ALT, ALP), Bilirubin (Direct and Total)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171230038142N16
Registration date: 2020-03-13, 1398/12/23
Registration timing: registered_while_recruiting

Last update: 2020-03-13, 1398/12/23
Update count: 0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation effects of the Livercare tablet (combination of Milk Thistle, Dandelion, Barberry, Tumeric (Curcumin) and Artichoke) in the prevention of anti-tuberculosis drugs-induced hepatotoxicity
Public title
The evaluation effects of the Livercare tablet (combination of Milk Thistle, Dandelion, Barberry, Tumeric (Curcumin) and Artichoke) in the prevention of anti-tuberculosis drugs-induced hepatotoxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20 to 65 Active pulmonary or extrapulmonary tuberculosis No first-line anti-tuberculosis drugs (isoniazid, rifampin, pyrazinamide) in all patients in the past 8 weeks and starting on treatment No known hepatotoxic drugs (sodium valproate, methotrexate and sulfonamides) No continuous use of acetaminophen No systemic glucocorticoids, supplements containing thistle, dandelion, barberry, turmeric or artichoke in the past 4 weeks
Exclusion criteria:
Patient dissatisfaction alcohol consumption liver disease Discontinue medication for any reason other than liver toxicity Patient Withdrawal from Study Continuation Not taking the study tablet for at least 3 consecutive days
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected from people with pulmonary or extrapulmonary tuberculosis referred to Alzahra Hospital in Isfahan. Forty-four of them will be randomly selected: In the first step, the patients will be selected sequentially. In the second step, randomized binary blocks are used, meaning that the first two individuals are eligible to form a block and then randomly assigned to the drug group and the control group to the placebo . The main drugs (Livercare) will then be given to the pharmacologist and will be ordered to make a placebo and then the original and placebo will be referred back to the researcher without being informed by the pharmacist about the originator or placebo. Two groups A and B are named, then two patients are randomly assigned to one A and the other to B and are decoded after completing the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are not excluded from the therapeutic content of other groups. On the other hand, the main drugs (Livercare) are given to the pharmacologist and he will order the preparation of the placebo (the pharmacist) then the original drugs and the placebo will be referred back to the researcher without the researcher being aware of the original or the placebo. They were assigned to groups A and B and were then assigned to one of the A and one of the B patients on a randomized two-block basis.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-05-16, 1398/02/26
Ethics committee reference number
IR.MUI.MED.REC.1398.038

Health conditions studied

1

Description of health condition studied
Tuberculosis
ICD-10 code
A15
ICD-10 code description
Respiratory tuberculosis

Primary outcomes

1

Description
Hepatic Enzymes (AST, ALT, ALP)
Timepoint
Before and one week and two weeks after intervention
Method of measurement
blood test

2

Description
Bilirubin (Direct and Total)
Timepoint
Before and one week and two weeks after intervention
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: All patients receive standard dose (by weight) treatment with first-line drugs (isoniazid, rifampin and pyrazinamide).In addition, for the intervention group, Livercare tablets, made by Health Aid, contain sperm powder (500 mg), dandelion root powder (200 mg), barberry root powder (200 mg), turmeric powder (200 mg) and powder Artichoke (200 mg) is prescribed twice a day for 2 weeks at the same time as starting anti-cellulite drugs.. Prior to the administration of the antiplatelet medications and interventions mentioned above, 5 ml of venous blood was taken from each patient in fasting state to measure liver enzymes (AST, ALT, ALP) and bilirubin (direct and total). During the study, the patient is screened weekly by a physician, and in addition to examining the patient for symptoms of hepatotoxicity, the serum levels of these parameters are determined at each visit. Hepatotoxicity, by increasing the serum level of ALT or AST liver enzymes by more than 5 times the maximum value without a clinical sign or more than 3 times the maximum value with clinical symptoms (such as nausea, vomiting, loss of appetite, upper abdominal pain). And jaundice) are defined. In case of hepatotoxicity caused by antiproliferative drugs, the administration of these drugs will be stopped.
Category
Prevention

2

Description
Control group: All patients receive standard dose (by weight) treatment with first-line drugs (isoniazid, rifampin and pyrazinamide).The control group will receive only standard anti-cellulite treatment with placebo. Prior to the administration of the antiplatelet medications and interventions mentioned above, 5 ml of venous blood was taken from each patient in fasting state to measure liver enzymes (AST, ALT, ALP) and bilirubin (direct and total). During the study, the patient is screened weekly by a physician, and in addition to examining the patient for symptoms of hepatotoxicity, the serum levels of these parameters are determined at each visit. Hepatotoxicity, by increasing the serum level of ALT or AST liver enzymes by more than 5 times the maximum value without a clinical sign or more than 3 times the maximum value with clinical symptoms (such as nausea, vomiting, loss of appetite, upper abdominal pain). And jaundice) are defined. In case of hepatotoxicity caused by antiproliferative drugs, the administration of these drugs will be stopped.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital in Isfahan
Full name of responsible person
Mohammad Reza Yazdani
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Mbn57m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Vice-Chancellor for Research of School of Medicine,. Isfahan University of Medical Sciences,. Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Yazdani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Mbn57m@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Yazdani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
Mbn57m@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Abrishami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Fax
Email
dadepardaz2005@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information is shared two years after the results are published.
When the data will become available and for how long
The information is shared two years after the results are published.
To whom data/document is available
Doctors and Infectious Diseases
Under which criteria data/document could be used
Comparison of the other treatment with the present one
From where data/document is obtainable
Send Mbn57m@gmail.com an email
What processes are involved for a request to access data/document
Send Mbn57m@gmail.com an email
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