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IRCT20230105057060N1 IRCT 2023-05-06 Yasouj University of Medical Sciences The effect of hydroalcoholic extract of Quercus brantii on acute watery diarrhea in children The effect of hydroalcoholic extract of Quercus brantii on acute watery diarrhea: A double-blind clinical trial 2022-09-23 anticipated 80 Complete https://irct.ir/trial/67891 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The technique of randomization is simple. The computer program "Computer Random Generation" will determine the assignment sequence. We will use sealed envelopes with codes to assign research units to the control and intervention groups (A, B), Blinding description: The study will be conducted in a double-blind manner, so that the pharmacist will provide researchers with 80 bottles containing medicine (500 mg of oak extract) and placebo, which will have a code on each of them. The researcher and patients are not aware of its contents. 0 (exploratory trials) Diarrhea in children. Intervention 1: The study is a randomized, a double-blind clinical trial including 80 children (6 to 6 years old) with severe watery diarrhea (no blood in stool and fewer than five white blood cells) for 3 to 6 days that were hospitalized in the hospital of Imam Sajjad Yasuj. The subjects are typically assigned to the control or intervention group using a simple random assignment method after completing an ethical form. The parents will being thoroughly informed about participating in the research. The study will begin after receiving the code of ethics from the university. Patients with watery diarrhea are admitted to Imam Sajjad Hospital in Yasuj city after taking a history and examining related tests, including blood and urine tests, including CBC-Diff, Na, K, BUN, Cr, BS, S/E. U/A are selected and randomly divided into two control and intervention groups, The study will be done in a double-blind manner. After preparing 80 bottles of simple syrup containing extract and placebo, the researcher and patient need to be made aware of the contents of the bottles because they are coded. The patient or the patient's companion is first given a questionnaire containing study variables such as fever, patient weight, and duration of hospitalization. The intervention group received 500 mg of oak extract orally in addition to the standard treatment for acute watery diarrhea (WHO protocol). In contrast, the control group received a placebo and the standard treatment for acute watery diarrhea (WHO protocol). The questionnaires are then filled out a second time with daily references for up to three days. After the collated questionnaires are made available to the statistician after the survey. In addition, supportive remedies, such as zinc and probiotics, are administered to aid in the regeneration of the villi. Intervention 2: Control group: placebo group:The same amount of placebo substance was used in containers that were completely similar to containers containing oak extract. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main outcome or the like, can be shared. When: 2023 To whom: Academic and scientific institutions Conditions: Data validation Where to obtain: Dr Zeynab Daneshi How to obtain: Contact the project manager Comments:
public Ali Keshtkari
Jalil Street
Yasouj Iran (Islamic Republic of) 7591994779 +98 74 3323 5137 a_keshtkari@yahoo.com Yasouj University of Medical Sciences scientific Ali Keshtkari
Jalil Street
Yasouj Iran (Islamic Republic of) 7591994779 +98 74 3323 5137 a_keshtkari@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Age between 6-72 month Acute watery diarrhea in children Informed consent of the patient's parents 6 months 6 years Both Chronic Diseases Severe malnutrition Bloody diarrhea Recent use of antibiotics Persistent vomiting Recent use of zinc supplements (last month) Drug intolerance R19.7 Diarrhea, unspecified Treatment - Drugs Treatment - Drugs The study is a randomized, a double-blind clinical trial including 80 children (6 to 6 years old) with severe watery diarrhea (no blood in stool and fewer than five white blood cells) for 3 to 6 days that were hospitalized in the hospital of Imam Sajjad Yasuj. The subjects are typically assigned to the control or intervention group using a simple random assignment method after completing an ethical form. The parents will being thoroughly informed about participating in the research. The study will begin after receiving the code of ethics from the university. Patients with watery diarrhea are admitted to Imam Sajjad Hospital in Yasuj city after taking a history and examining related tests, including blood and urine tests, including CBC-Diff, Na, K, BUN, Cr, BS, S/E. U/A are selected and randomly divided into two control and intervention groups, The study will be done in a double-blind manner. After preparing 80 bottles of simple syrup containing extract and placebo, the researcher and patient need to be made aware of the contents of the bottles because they are coded. The patient or the patient's companion is first given a questionnaire containing study variables such as fever, patient weight, and duration of hospitalization. The intervention group received 500 mg of oak extract orally in addition to the standard treatment for acute watery diarrhea (WHO protocol). In contrast, the control group received a placebo and the standard treatment for acute watery diarrhea (WHO protocol). The questionnaires are then filled out a second time with daily references for up to three days. After the collated questionnaires are made available to the statistician after the survey. In addition, supportive remedies, such as zinc and probiotics, are administered to aid in the regeneration of the villi. Control group: placebo group:The same amount of placebo substance was used in containers that were completely similar to containers containing oak extract. Children's weight. Timepoint: Hospitalization period. Method of measurement: Balance. Frequency of diarrhea. Timepoint: The first and the last day of hospitalization. Method of measurement: Questionnaire. Stool consistency. Timepoint: Examining stool consistency (watery, soft and hard) on the first, second and third day based on the daily stool consistency record form (Bristol scoring form). Method of measurement: Questionnaire. Blood and urine tests including CBC-Diff, Na, K, BUN, Cr, BS, S/E, U/A. Timepoint: Before and after the study period. Method of measurement: Laboratory. Yasouj University of Medical Sciences Approved 2022-05-18 Research Ethics Committees Jalil Yasuj Kermanshah Iran (Islamic Republic of)