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IRCT20171230038142N16 IRCT 2020-03-13 Esfahan University of Medical Sciences 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 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 2019-07-23 anticipated 44 Complete https://irct.ir/trial/46032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Tuberculosis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The information is shared two years after the results are published. When: The information is shared two years after the results are published. To whom: Doctors and Infectious Diseases Conditions: Comparison of the other treatment with the present one Where to obtain: Send Mbn57m@gmail.com an email How to obtain: Send Mbn57m@gmail.com an email Comments:
public Mohammad Reza Yazdani
Al-Zahra Hospital, Sofah Boulevard.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 Mbn57m@gmail.com Esfahan University of Medical Sciences scientific Mohammad Reza Yazdani
Isfahan University of Medical Sciences, Hazar Jarib Street
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8597 Mbn57m@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 65 years Both 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 A15 Respiratory tuberculosis Prevention Placebo 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. 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. Hepatic Enzymes (AST, ALT, ALP). Timepoint: Before and one week and two weeks after intervention. Method of measurement: blood test. Bilirubin (Direct and Total). Timepoint: Before and one week and two weeks after intervention. Method of measurement: blood test. Esfahan University of Medical Sciences Approved 2019-05-16 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan Isfehan Iran (Islamic Republic of)