]>
IRCT20181107041586N1 IRCT 2019-08-10 Mazandaran University of Medical Sciences Evaluation of efficacy of "Ziziphus Vulgaris" formula to prevent “drug induced liver enzyme disorder” in pulmonary tuberculosis Patients Evaluation of efficacy of “Ziziphus Vulgaris” formula to prevent “drug induced liver enzyme disorder” in pulmonary tuberculosis Patients 2019-07-21 anticipated 70 Complete https://irct.ir/trial/40383 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients referring to health centers diagnosed with TB by a doctor who have criteria for entry into the study are included in the study. 70 samples will be assigned to two groups using the Block Random allocation method. The sample allocation will be done using the software, and samples will be assigned in binary blocks, ie, random numbers for blocks from Through the application. Patients will be placed in two groups A and B using the Randomization Block. Group A is given to the group B and placebo. In order to hide the random allocation of the groups, the method of packet envelopes will be used. Then the envelopes are opened for the patient, and the treatment is determined, Blinding description: Due to the similarity of the drug & placebo, after randomization and allocation of subjects to the two groups of study, the drugs were placed in the box and encoded. In this way, the patient and expert assessor and researcher will not be aware from type of intervention. Jujube & placebo syrups are similar in appearance and concentration, and until the end of the data analysis, they will remain hidden from the study's participants and participants (double blind). 3 drug-induced hepatotoxicity. Intervention 1: Intervention group: Patients are treated with jujube-based syrup for a month receiving 10 cc of the syrup two times a day, fasting morning and half an hour before bedtime. Routine anti-TB treatment will be implemented in accordance with the DOTs Country Program. Intervention 2: Control group: The control group receives placebo syrup.Routine anti-TB treatment will be implemented in accordance with the DOTs Country Program. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Assie Jokar
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 a.jokar@mazums.ac.ir Mazandaran University of Medical Sciences scientific Assie Jokar
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 a.jokar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Declaration of written consent of the volunteer for participation in the trial Age from 30 to 65 years A new diagnosis of pulmonary tuberculosis by an infectious disease specialist or a health center doctor No relapse or drug resistance No history of HIV-positive No history of renal failure No history of all types of acute and chronic and alcoholic hepatitis No history of cirrhosis No Pregnancy and lactation 30 years 65 years Both Patients under treatment with other herbal supplements Lack of appropriate verbal communication Patients with Oral intolerance No tendency to take herbal medicine No tendency to consume syrup K71.9 Toxic liver disease, unspecified Prevention Placebo Intervention group: Patients are treated with jujube-based syrup for a month receiving 10 cc of the syrup two times a day, fasting morning and half an hour before bedtime. Routine anti-TB treatment will be implemented in accordance with the DOTs Country Program. Control group: The control group receives placebo syrup.Routine anti-TB treatment will be implemented in accordance with the DOTs Country Program. Serum level of alanine aminotransferase. Timepoint: At the beginning of the study (before the intervention),The end of the second week and at the end of the intervention. Method of measurement: Biochemical tests. Serum level of aspartate aminotransferase. Timepoint: At the beginning of the study (before the intervention),The end of the second week and at the end of the intervention. Method of measurement: Biochemical tests. Serum level of Alkalin phosphatase. Timepoint: At the beginning of the study (before the intervention),The end of the second week and at the end of the intervention. Method of measurement: Biochemical tests. Mazandaran University of Medical Sciences Approved 2019-05-18 ethic committee of Mazandaran University of Medical Sciences Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square Sari Mazandaran Iran (Islamic Republic of)