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IRCT20230606058390N1 IRCT 2023-07-01 Babol University of Medical Sciences Effect of Dimenhydrinate on Heart Rate Variability (HRV) Assessment of Cardiac autonomic system responses to oral administration of Dimenhydrinate in healthy young subjects 2023-07-06 anticipated 15 Complete https://irct.ir/trial/70931 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Basic scienece, Randomization description: Using a table of random numbers, a three-digit code is inserted on each pack These packs are divided into two drug or placebo groups None of the studied person and the researcher know about its type Each person will be given two packs with two identical pills, each of which will be Dimenhydrinate 50 mg or placebo. To randomize the above process, a 3-digit code will be written on each pack and this number will be included on each person's checklist. It is explained to the participants of the study that in the first week they will take the first pack of pills and two weeks later, they will take the second pack of pills , Blinding description: Each person will be given two packs with two identical pills, each of which will be Dimenhydrinate 50 mg or placebo. None of the studied person and the researcher know about its type To randomize the above process, a 3-digit code will be written on each pack and this number will be included on each person's checklist. It is explained to the participants of the study that in the first week they will take the first pack of pills and two weeks later, they will take the second pack of pills . 1 Assessment of Cardiac autonomic system responses to oral administration of Dimenhydrinate in healthy subjects. At the beginning of the intervention, each participant is given a pack with a three-digit code that contains 50 mg Dimenhydrinate tablets or placebo, then every half an hour, ECG is taken using HRV recorder and epobe software for 4 hours. Two weeks later, the second pack is given and the ECG is taken every half an hour for 4 hours. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr Roghayeh Pourkia
Babol University of Medical Sciences, Keshavarz Boulevard
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 dr.pourkia@yahoo.com Babol University of Medical Sciences scientific Dr Roghayeh Pourki
Babol University of Medical Sciences, Keshavarz Boulevard
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 dr.pourkia@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Healthy subjects Normal Body Mass Index (BMI) 19 to 26 years olds 19 years 26 years Both Smoking Alcohol consumption Substance abuse Cardiovascular diseases Acute and chronic diseases Prohibition of Dimenhydrinate N/A At the beginning of the intervention, each participant is given a pack with a three-digit code that contains 50 mg Dimenhydrinate tablets or placebo, then every half an hour, ECG is taken using HRV recorder and epobe software for 4 hours. Two weeks later, the second pack is given and the ECG is taken every half an hour for 4 hours The effect of Dimenhydrinate 50 mg tablets on HRV. Timepoint: Before starting the intervention and every 30 minutes after the start of taking Dimenhydrinate tablets 50 mg or placebo for 4 hours. Method of measurement: HRV recording device and eprobe software. Babol University of Medical Sciences Approved 2023-05-29 Ethics committee of Babol University of Medical Science Babol University of Medical Sciences, Keshavarz Boulevard Babol Mazandaran Iran (Islamic Republic of)