Evaluating the effects of the traditional wheat product (saviq) on the pattern of changes caused bychemotherapy in the gastrointestinal tract of children with acute lymphoblastic leukemia referred to the Imam Rezaclinic in 1401 - a triple-blind clinical trial

Determining the effect of traditional wheat bran product on reducing the incidence of chemotherapeutic gastrointestinal complications in children with acute lymphoblastic leukemia undergoing chemotherapy

Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 80 patients. For randomization in this study, the Restricted randomization method of block randomization has been used.

Samples were randomly selected from children aged 3 to 18 years with acute leukemia undergoing chemotherapy referred to Imam Reza's clinic in Shiraz and were divided into case and control groups. Intervention period: 4 weeks Before starting the study, patients will be divided into two groups A and B based on the attached checklist by block randomization method. The patient-level study will evaluate the outcome and statistically analyze the results. Only the drug maker can decode the contents of each sachet based on the original form stored in the randomization results. The person in charge of drug delivery, the patient, the doctor and the person in charge of evaluating the consequences will not know about the codings.

Inclusion criteria: Children 3-18 years old with lymphoblastic leukemia undergoing chemotherapy Conditions of non-admission: Children in very serious condition and with a ban on treating physicians or candidates for surgery and extensive antibiotic treatment

The traditional product "Wheat saviq with jollab" is given as a "complementary food" and "refined wheat flour with jollab equivalent syrup" as "placebo" is given to the case and control groups.

Prevention of gastrointestinal symptoms (diarrhea, constipation, bloating, dyspepsia, anorexia, nausea, vomiting, abdominal pain) in patients in the intervention group compared to the control group

Randomization 1- Sequence generation (method used to generate random allocation sequence) 2- Randomization type, details of any constraints In this study, we will use the restricted randomization method of block randomization. The size of all blocks is equal and in this two-group experiment we will have 4 blocks (including 2 participants in the intervention group and 2 participants in the control group). For each of the 6 possible cases for the quadruple block, the numbers are assigned as follows. AABB=1, ABAB=2, BBAA=3, BABA=4, ABBA=5, BAAB=6 With the help of a table of random numbers, the numbers between 1 and 6 are selected and the treatment allocation list is determined according to each number. In this three-blind trial, in addition to patients, researchers and analysts are unaware of which person is receiving the drug or placebo. Only the drug maker can decode the contents of each sachet based on the original form stored in the randomization results. Participant allocation concealment method (mechanism used to randomize participant allocation (such as consecutive numbered containers) and explain all the steps that can be taken to hide the sequence until the intervention is assigned to each group We use concealment allocation, which is the method used to execute random sequences on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed in random sequence (envelopes opaque, sealed, numbered Sequentially) In this method, each of the random sequences created is recorded on a card and the cards are placed in envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. (Who determines the random allocation sequence? Who enters the study participants? Who assigns the participants to the intervention groups?) A trained person outside the research team is responsible for randomly assigning patients, and at the time of registration of participants, they provide the participant with one of the sealed letter envelopes according to the order of entry of eligible participants. Put it to deliver to the researcher and he after opening the envelope, the group assigned to that participant, is determined for him and delivers the medicine package.

Before starting the study, patients will be divided into two groups A and B based on the attached checklist by block randomization method. Supplemental and placebo sachets will also be divided into containers labeled A and B by the drug manufacturer. Group A patients will receive drug A and group B patients will receive drug B. Study at the patient level, outcome assessor and statistical analyzer of the results will be blinded. Only the manufacturer of the drug can decode the contents of each sachet based on the original form stored in the randomization results. The person in charge of drug delivery, the patient, the doctor and the person in charge of evaluating the consequences will not know about the codings. The results of the two groups will be submitted to the statistical analyst under the headings of groups A and B.

Part of the data can be shared, such as information about demographic characteristics and its main outcome.

The access period starts six months after the results are published

It will be available only to researchers working in academic and scientific institutions.

Only for researchers who want to do meta-analysis and systematic review

zohalinm@sums.ac.ir Mohammad Ebrahim Zahlinezhad Assistant Professor of Persian Medicine and History of Medicine 00989173026200

Evaluation of the letter and details of the request by the supervisor and the main executor of the project And presentation of the issue in the weekly group meeting Estimated time: about two weeks