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IRCT20220410054474N1 IRCT 2022-05-24 Shiraz University of Medical Sciences 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 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 2022-05-22 anticipated 58 Complete https://irct.ir/trial/62933 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 3 Acute Lymphoblastic Leukemia. Intervention 1: Intervention group: Intervention group: The traditional product of "wheat bran" is given to the case group as a "complementary food". It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The product is given to the mother in the form of powder and the recipe is as follows: mix with boiling water and add Jollab syrup (which is given to the mother along with medicine sachets) and cook it briefly until it becomes halva. Jollab syrup (a combination of rose, saffron and sugar) is delivered to the mother ready with sachets containing soybean. The method of combining suviq and jollab will be explained to the mother both in writing and orally.Remove the resulting mixture from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, according to the dose of saviq.A short video of the work process was also sent to them. Product: Whole wheat saviq with jollab syrup - Jollab syrup preparation formula: three liters of rose water per kilogram of sugar + half a pound of saffron (about two grams) _ daily consumption of children depending on their age and weight between 20-30 grams Saviq. The jollab syrup is purchased from a pharmaceutical company and saviq is produced by the pharmacist of the study. Intervention 2: "Refined wheat flour" is given to the control group as a placebo. It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The placebo is given to the mother in the form of powder and the recipe is as follows: Placebo syrup (which is given to the mother along with placebo sachets) and cook it briefly until it becomes halva. In the placebo group, a syrup with the same color, taste and aroma of jalab is given, which is without rose and saffron and contains only a small amount of essential oil. The method of mixing flour and syrup will also be explained to the mother in writing orally. Remove from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, depending on the dose of flour) (a short video of the steps will be sent to them. The daily consumption of children, depending on their age and weight, is between 20-30 grams per day. The syrup used in the study is purchased from a pharmaceutical company and the consumed flour is purchased from a specific brand in the market. Yes - There is a plan to make this available What will be shared: Part of the data can be shared, such as information about demographic characteristics and its main outcome. When: The access period starts six months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: Only for researchers who want to do meta-analysis and systematic review Where to obtain: zohalinm@sums.ac.ir Mohammad Ebrahim Zahlinezhad Assistant Professor of Persian Medicine and History of Medicine 00989173026200 How to obtain: 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 Comments:
public Saba Barkhori mehni
Persian Medicine School, 7th floor, Medicine school, Zand street, Shiraz
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۴۵۷۹۴ +98 71 3234 5145 saba.barkhori@gmail.com Shiraz University of Medical Sciences scientific Mohammad Ebrahim Zohali nejad
Persian Medicine School, 7th floor, Medicine School, Zand street, Shiraz
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۴۵۷۹۴ +98 71 3234 5145 zohalinm@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Children aged 3-18 years with severe lymphoblastic leukemia treated in the post-consolidation period. 3 years 18 years Both Severely ill patients Patients who must be prescribed fasting by physician Patients with broad-spectrum antibiotics Patients with active infection Patients with celiac disease Those requiring gastrointestinal surgery Neutropenic patients C91.01 Acute lymphoblastic leukemia, in remission Other Placebo Intervention group: Intervention group: The traditional product of "wheat bran" is given to the case group as a "complementary food". It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The product is given to the mother in the form of powder and the recipe is as follows: mix with boiling water and add Jollab syrup (which is given to the mother along with medicine sachets) and cook it briefly until it becomes halva. Jollab syrup (a combination of rose, saffron and sugar) is delivered to the mother ready with sachets containing soybean. The method of combining suviq and jollab will be explained to the mother both in writing and orally.Remove the resulting mixture from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, according to the dose of saviq.A short video of the work process was also sent to them. Product: Whole wheat saviq with jollab syrup - Jollab syrup preparation formula: three liters of rose water per kilogram of sugar + half a pound of saffron (about two grams) _ daily consumption of children depending on their age and weight between 20-30 grams Saviq. The jollab syrup is purchased from a pharmaceutical company and saviq is produced by the pharmacist of the study. "Refined wheat flour" is given to the control group as a placebo. It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The placebo is given to the mother in the form of powder and the recipe is as follows: Placebo syrup (which is given to the mother along with placebo sachets) and cook it briefly until it becomes halva. In the placebo group, a syrup with the same color, taste and aroma of jalab is given, which is without rose and saffron and contains only a small amount of essential oil. The method of mixing flour and syrup will also be explained to the mother in writing orally. Remove from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, depending on the dose of flour) (a short video of the steps will be sent to them. The daily consumption of children, depending on their age and weight, is between 20-30 grams per day. The syrup used in the study is purchased from a pharmaceutical company and the consumed flour is purchased from a specific brand in the market. Occurrence of gastrointestinal symptoms. Timepoint: Beginning and end of the intervention; Days 0 and 28. Method of measurement: Pediatrics Quality of Life Questionnaire - gastrointestinal symptoms scales version 3.0. "Quality of life" of children - "Weight" of the child - "Blood test (CBC)" - "Gastrointestinal microbiome" - "Number of colonies created by the collection of bacteria in the feces". Timepoint: All variables will be measured on day 0 and day 28 after the intervention. Method of measurement: TAPQOL Quality of Life Questionnaire for Preschool Children (1-6 years old) and PedsQL Questionnaire for Quality of Life of Preschool Children- "Weight" of the child on day 0 and day 28 after the intervention"Blood test (CBC)" to check for blood factors including WBC Plt Hb RBC on day 0 and day 28 after intervention - "Stool test" of the child and performing Real-Time PCR to measure and determine the gastrointestinal microbiome on day 0 and day 28 after the intervention- Counting the number of colonies created by the collection of bacteria in the feces by microdilution culture on day 0 and 28 of the intervention. Research Center for Traditional Medicine and History of Medicine Shiraz University of Medical Sciences Research Center for Traditional Medicine and History of Medicine Approved 2022-02-22 Ethics committee of Shiraz University of Medical Sciences Persian medicine school, 9th floor, Medicine school, Zand street shiraz Fars Iran (Islamic Republic of)