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IRCT20230701058637N1 IRCT 2023-08-03 Babol University of Medical Sciences Effect of Ginger on Heart Rate Variability (HRV) Effect of single dose administration of ginger on frequency domain heart rate variability measures in young healthy subjects 2023-08-05 anticipated 30 Complete https://irct.ir/trial/71593 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 capsules, each of which will be Ginger 250 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 capsules and two weeks later, they will take the second pack of capsules , Blinding description: Each person will be given two packs with two identical capsules, each of which will be Ginger 250 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 capsules and two weeks later, they will take the second pack of capsules . 1 young healthy subjects. Intervention 1: Intervention group: At the beginning of the intervention, each participant is given a pack with a three-digit code that contains 250 mg Ginger capsules or placebo, then every half an hour, ECG will be taken using HRV recorder and ePobe software for 4 hours. Intervention 2: Control group: Two weeks later a second pack with three-digit code that contains 250 mg Ginger capsule or placebo will be given to the same participants then every half an hour, ECG will be taken using HRV recorder and ePobe software 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 Iraj Jafaripour
Babol University of Medical Sciences, Keshavarz Boulevard
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 i.jafaripour@mubabol.ac.ir Babol University of Medical Sciences scientific Dr Iraj Jafaripour
Babol University of Medical Sciences, Keshavarz Boulevard
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 i.jafaripour@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Healthy subjects Normal Body Mass Index (BMI) 19 to 26 years old 19 years 26 years Both Smoking Alcohol consumption Substance abuse Cardiovascular diseases Acute and chronic diseases Prohibition of Ginger N/A N/A Intervention group: At the beginning of the intervention, each participant is given a pack with a three-digit code that contains 250 mg Ginger capsules or placebo, then every half an hour, ECG will be taken using HRV recorder and ePobe software for 4 hours. Control group: Two weeks later a second pack with three-digit code that contains 250 mg Ginger capsule or placebo will be given to the same participants then every half an hour, ECG will be taken using HRV recorder and ePobe software for 4 hours The effect of Ginger 250 mg capsules on HRV. Timepoint: Before starting the intervention and every 30 minutes after the start of taking Ginger 250 mg capsules or placebo for 4 hours. Method of measurement: HRV recording device and eprobe software. Babol University of Medical Sciences Approved 2023-07-25 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Keshavarz Boulevard Babol Mazandaran Iran (Islamic Republic of)