Investigating the effect of Syrup based on Naqu Fawakeh on liver enzymes in children with ALL undergoing chemotherapy ,a double blind randomized controlled trial.

Determining the effect of herbal syrup Naqu Fawakeh in comparison to Silymarin on liver enzymes in children aged 5 to 17 years old with ALL under chemotherapy, a double-blind clinical trial

This study is a controlled, parallel-group, double-blind, randomized, phase 3 clinical trial. For randomization the permutation block randomization method with four blocks will be used.

This study will be done in Imam Reza Clinic of Shiraz Faculty of Medical Sciences. According to the block randomization table (using the software), the patients are placed in two intervention groups by taking Naqu Fawake syrup and the control group by taking Silymarin syrup. To make the study blind, the drugs are in identical color and shape bottles , and a ten-digit code will be printed on each bottle. both patient and researcher are blinded to the study, but the statistical analyst is aware of the type of medication that the patients take.

Entry conditions: ALL Patients based bone marrow aspiration, immunophenotype, in treatment maintenance phase while taking methotrexate, 6-mercaptopuril, and have 2 or more times liver enzymes above the maximum normal level Non-entry : Allergy to herbal medicines or medicines that damage the liver. liver disease, HIV, diabetes, diarrhea, malignancies and chronic intestinal diseases

Intervention group: 53 people take Fitobile syrup between the ages of 5 - 12 , 5cc 3 times a day, and ages 12-17 , 1 tablespoon 3 times a day, 3 hours after each meal. Control group: 53 people take Silymarin syrup, 2cc (children under 30kg), 4cc (children over 30kg) 3 times a day after meal.

Liver and kidney function tests, blood cell count, constipation, nausea and vomiting

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.

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.

Confidentiality