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IRCT20231119060105N1 IRCT 2023-11-25 Arak University of Medical Sciences Evaluation of the effect of vitamin E in reducing the duration of treatment in children with gastroenteritis Evaluation of the effect of vitamin E in reducing the duration of treatment in children with gastroenteritis 2023-10-01 anticipated 60 Complete https://irct.ir/trial/73896 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done, for this purpose, the participants will be assigned to two intervention and control groups according to the order of arrival and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. . Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced. 2 gastroenteritis. Intervention group: intervention group In addition to routine treatment, which includes fluid therapy and ORS, receive vitamin E drops from "Bahsa" company, each milliliter of which contains 10 international units of vitamin E, for 10 days according to age as follows We use: age 1-3 years: 18 drops equal to 0.90 ml; Age 4-8 years: 21 drops equal to 1.05 ml; Age 9-13 years: 33 drops equal to 1.65 ml. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions, as well as people working in the industry, can apply for them Conditions: There are no other conditions Where to obtain: To the main person responsible for the study; Dr. Ali Arjmand can be contacted at Aliarjmand1@yahoo.com How to obtain: The applicant can contact the person in charge of the study through the email address and get access to the information as soon as possible after the request Comments:
public Dr. Ali Arjmand
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
Arak Iran (Islamic Republic of) 3819693181 +98 86 3313 4715 Aliarjmand1@yahoo.com Arak University of Medical Sciences scientific Dr. Ali Arjmand
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
Arak Iran (Islamic Republic of) 3819693181 +98 86 3313 4715 Aliarjmand1@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All children aged 1-13 years with acute gastroenteritis referred to Amirkabir Hospital, whose acute gastroenteritis was confirmed by a pediatric specialist based on the symptoms of diarrhea, vomiting, abdominal pain and dehydration. Informed consent to participate in the study 1 year 13 years Both Children who cannot tolerate oral vitamin E People who do not cooperate. A09 Infectious gastroenteritis and colitis, unspecified Treatment - Drugs Intervention group: intervention group In addition to routine treatment, which includes fluid therapy and ORS, receive vitamin E drops from "Bahsa" company, each milliliter of which contains 10 international units of vitamin E, for 10 days according to age as follows We use: age 1-3 years: 18 drops equal to 0.90 ml; Age 4-8 years: 21 drops equal to 1.05 ml; Age 9-13 years: 33 drops equal to 1.65 ml The effect of vitamin E on reducing the duration of diarrhea, vomiting, abdominal pain, fever, anorexia and dehydration in gastroenteritis patients.​. Timepoint: The beginning of the intervention and the end of symptoms. Method of measurement: Through history and questionnaire. Arak University of Medical Sciences Approved 2023-09-30 Ethics committee of Arak University of Medical Sciences Arak University of medical science, Basij square Arak Markazi Iran (Islamic Republic of)