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IRCT20230810059110N1 IRCT 2023-11-01 Shiraz University of Medical Sciences Investigating the effect of Syrup based on Naqu Fawakeh on liver enzymes in children with ALL undergoing chemotherapy ,a double blind randomized controlled trial. Investigating the effect of Syrup based on Naqu Fawakeh on liver enzymes in children with ALL undergoing chemotherapy ,a double blind randomized controlled trial. 2023-11-06 anticipated 106 Complete https://irct.ir/trial/72003 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permutation block randomization method with blocks of four will be used (using random allocation software). This method is one of the most widely used random methods that guarantees equality of groups to a large extent. For this purpose, first we name the groups A or B. then we consider the different permutations of 4 letters of these two letters, of course, you can also consider the blocks with the size of 2 and 6, etc. But blocks with size 4 have been used more. Four permutations of two letters A and B are AABB, ABAB, ABBA, BBAA, BABA, BAAB. Each of these is a block of size 4, which includes two Patients from the experimental group and two from control Patients , for example, AABB permutation means that the first and second Patients are selected from group A (group A can be the test or the control group) and The second two Patients are assigned to group B (group B can be the experiment or the control group), then randomly by throwing a coin, we determine which A or B are the experiment group and which one is control group, for example, suppose A is the experimental group and B is the control group. Then we assign each of these 6 permutations to the numbers from 1 to 6 in the following order. 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB Now, using the table of random numbers, we extract numbers from the table sequentially, and we consider the digit of the extracted random numbers, which are one of the numbers 0 to 9, and depending on whether one of the numbers 1 to 6 comes, each of the blocks We select the numbers assigned to these numbers. With this calculation, we need 27 random numbers, which we use the rule of using the table of random numbers to extract these 27 numbers until 27 blocks of 4 are selected. If the numbers 0, 7, 8, and 9 come, we ignore them and continue this order to provide a complete list for the entire sample volume. Randomization using a computer can also be used for implementation in this regard. The randomization sequence is determined by the statistician in coordination with the pharmacist. The questioner enters the participants into the plan and determines the block of each patient according to the variables, then each patient is given a code, and according to that, the bottle with the corresponding code label is delivered to the patient by the trained personnel in the pharmacy of Imam Reza Hospital. The questioner does not know the contents of the bottles. Hide the random allocation, ten-digit codes will be printed on the bottles in coordination with the statistician and the pharmacist. The codes related to each block are randomized, identified and provided to the patient by the interviewer before the initial evaluation, and Naqu Fawakeh (Fitobile) and Silymarin (Livertrap) syrup are in bottles that are completely similar in color and shape. and similar labels are attached to the company's bottle, Blinding description: Participants and service providers are blinded to the intervention until the end of the design and presentation of statistical results. Naqoo Fawake Syrup (Fitobile) and Silymarin (Livertrap) are in completely similar bottles in terms of color and shape, and similar labels are attached to the company's bottles. To hide the random allocation, ten-digit codes will be printed on the bottles in coordination with the statistician and the pharmacist. The codes related to each randomized block are specified and provided to the patient by the interviewer before the initial evaluation. The pharmacist is aware of the contents of the bottles (Effervescence and Silymarin). The statistician who prepares the blocks and tables of random numbers is aware of the content of the codes. In order to blind the researcher, after the visit and receiving the relevant code, the patient goes to Imam Reza Pharmacy to receive the medicine, and the medicine is delivered to the patient based on the code by the trained staff of the pharmacy, and the way to take the medicine is given to the patient and his companion based on age and weight. They explain. 3 Elevation of liver enzymes caused by chemotherapy. Intervention 1: Intervention group: Intervention group: Naqu Fawake syrup containing Bukhara plums, black plums, mangosteens, jujubes, jaggery, tamarinds, apricots, and red sugar, which is currently manufactured under the brand name of Fitobile Syrup by Faratab Company, in the amount of 5 cc 3 times a day, 3 hours later Each meal at the age of 5 to 12 years and 1 tablespoon a day 3 hours after each meal at the age of 12 to 17 years is given for 8 weeks. Intervention 2: Control group: Control group: The control group is given silymarin syrup from Hakim Momin Tabrizi company and according to the amount of 120 mg of silymarin per 5 cc, in children under 30 kg 2 cc 3 times a day after each meal and for children over 30 Kilo 4 cc is given 3 times a day after each meal. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality
public Yasman Vazani
Zand St., Medical School, 7th floor, Department of Iranian Medicine
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 Yasaman.vazani@gmail.com Shiraz University of Medical Sciences scientific Yasman Vazani
Zand St., Medical School, 7th floor, Department of Iranian Medicine
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 Yasaman.vazani@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with ALL based on bone marrow aspiration and immunophenotype, aged 5 to 17 years, in the maintenance phase of treatment by methotrexate and 6-mercaptopuril, with liver enzymes level 2 times or more higher than the maximum normal level Willingness to participate in the study . 5 years 17 years Both The occurrence of any allergy and intolerance to the drug. Diagnosis of liver disease during planning. The patient's unwillingness to continue treatment. Taking drugs that interfere with the herbs in the composition. history of drug sensitivity to the plants in the syrup:Prunus cerasus,Prunus domestica,Alhagi pseudalhagi ,Zizyphus jujube,Cordia myxa ,Tamarindus indica,Prunus armeniaca,Saccharum officinarum The patient has diarrhea. (CTCAE questionnaire)[39] history of liver disease, viral hepatitis, HIV, diabetes, other malignancies, and chronic intestinal disease. Taking drugs with the risk of cholestatic liver damage or damaging liver cells: drugs causing liver cholestasis: amoxicilline and clavulanic acid with consumption of more than 90 mg per kilogram per day, anabolic steroids, chlorpromazin, clopidogrel, erythromycin, irbesartan, mirtazapine, estrogen , terbinafine, drugs that damage liver cells and cause liver cholestasis, amitriptyline, azathioprine: captopril, carbamazepine, clindamycin, co-trimoxazole, cyproheptadine, enalapril, flutamide, nitrofurantoin, phenobarbital, phenytoin, sulphonamide, trazodone, verapamil K71.6 Toxic liver disease with hepatitis, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Naqu Fawake syrup containing Bukhara plums, black plums, mangosteens, jujubes, jaggery, tamarinds, apricots, and red sugar, which is currently manufactured under the brand name of Fitobile Syrup by Faratab Company, in the amount of 5 cc 3 times a day, 3 hours later Each meal at the age of 5 to 12 years and 1 tablespoon a day 3 hours after each meal at the age of 12 to 17 years is given for 8 weeks. Control group: Control group: The control group is given silymarin syrup from Hakim Momin Tabrizi company and according to the amount of 120 mg of silymarin per 5 cc, in children under 30 kg 2 cc 3 times a day after each meal and for children over 30 Kilo 4 cc is given 3 times a day after each meal Alanine transaminase (ALT). Timepoint: before the start of the intervention and 28, 84, 56 days after the start of the drug. Method of measurement: Blood test. Aspartate transaminase(ASP). Timepoint: before the start of the intervention and 28, 84, 56 days after the start of the drug. Method of measurement: Blood test. Alkaline Phosphatase( ALP ). Timepoint: before the start of the intervention and 28, 84, 56 days after the start of the drug. Method of measurement: Blood test. Constipation. Timepoint: At the beginning of the study (before the start of the intervention) and 28, 56, 84 days after the start of the drug. Method of measurement: Criteria Terminology Common For Adverse Events (CTCAE) version4 ,questionnaire. Nausea and Vomiting. Timepoint: At the beginning of the study (before the start of the intervention) and 28, 56, 84 days after the start of the drug. Method of measurement: MAT questionnaire. Shiraz University of Medical Sciences Approved 2023-06-26 Ethics committee of Shiraz University of Medical Sciences Zand St., Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)