Effect of Ginger 250 mg capsule consumption on frequency domain heart rate variability measures in young healthy subjects
Design
Randomised, double-blind, phase 1, clinical trial with crossover placebo control to evaluate effect of single dose administration of ginger on frequency domain heart rate variability measures in young healthy subjects. A table of random numbers is used for randomisation.
Settings and conduct
In Rouhani Hospital, at the beginning of the intervention, 30 healthy young subjects between 19 to 26 years old with normal BMI will be given a pack with a three-digit code that contains Ginger 250 mg capsule or placebo. then ECG is taken every 30 minutes by Heart Rate Variability recording device and eProbe software for 4 hours. Two weeks later every 30 participants are given a second pack and the ECG is taken again.
Participants/Inclusion and exclusion criteria
Healthy young individuals between 19 to 26 years old with normal Body Mass Index
Intervention groups
At the beginning of the intervention, each participant will be given a pack with a three-digit code that contains Ginger 250 mg capsule or placebo, then every 30 minutes for 4 hours, ECG is taken using HRV recorder and ePobe software. Two weeks later, the second pack will be given and the ECG will be taken every half an hour for 4 hours. The data will be analyzed using Prism statistical software version SPSS 25 And thus, the effect of Ginger 250 mg capsule on the frequency domain heart rate variability measures can be evaluated.
Main outcome variables
Effect of Ginger 250 mg capsules on Heart Rate Variability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230701058637N1
Registration date:2023-08-03, 1402/05/12
Registration timing:prospective
Last update:2023-08-03, 1402/05/12
Update count:0
Registration date
2023-08-03, 1402/05/12
Registrant information
Name
Iraj Jafaripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
i.jafaripour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-05, 1402/05/14
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single dose administration of ginger on frequency domain heart rate variability measures in young healthy subjects
Public title
Effect of Ginger on Heart Rate Variability (HRV)
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects
Normal Body Mass Index (BMI)
19 to 26 years old
Exclusion criteria:
Smoking
Alcohol consumption
Substance abuse
Cardiovascular diseases
Acute and chronic diseases
Prohibition of Ginger
Age
From 19 years old to 26 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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 .
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-07-25, 1402/05/03
Ethics committee reference number
IR.MUBABOL.REC.1402.045
Health conditions studied
1
Description of health condition studied
young healthy subjects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
N/A
2
Description
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
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Dr Iraj Jafaripour
Street address
Rouhani Hospital, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
i.jafaripour@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Iraj Jafaripour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Babol University of Medical Sciences, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
i.jafaripour@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Iraj Jafaripour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Babol University of Medical Sciences, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
i.jafaripour@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Iraj Jafaripour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Babol University of Medical Sciences, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
i.jafaripour@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available