Evaluation of cardiac autonomic nervous system response to oral consumption of Dimenhydrinate in healthy young volunteers.
Design
Double-blind clinical trial with crossover placebo control to evaluate cardiac autonomic nervous system response to oral Diaminehydrinate 50 mg in 15 healthy young volunteers. A table of random numbers is used for randomization
Settings and conduct
In Rouhani Hospital, at the beginning of the intervention, 15 healthy young subjects aged 19 to 26 years old with normal BMI are given a pack with a three-digit code that contains Dimenhydrinate 50 mg tablets or placebo. then ECG is taken every half an hour by HRV recording device and eprobe software for 4 hours. Two weeks later every 15 participants are given a second pack and the ECG is taken again.
Participants/Inclusion and exclusion criteria
Healthy young individuals aged 19 to 26 years old with normal BMI
Intervention groups
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 data will be analyzed using Prism statistical software version spss229
And thus, the effect of Dimenhydrinate 50 mg tablets on the response of the cardiac autonomic nervous system can be evaluated.
Main outcome variables
The effect of Dimenhydrinate 50 mg tablets on HRV
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230606058390N1
Registration date:2023-07-01, 1402/04/10
Registration timing:prospective
Last update:2023-07-01, 1402/04/10
Update count:0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Roghayeh Pourkia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
dr.pourkia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Cardiac autonomic system responses to oral administration of Dimenhydrinate in healthy young subjects
Public title
Effect of Dimenhydrinate on Heart Rate Variability (HRV)
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects
Normal Body Mass Index (BMI)
19 to 26 years olds
Exclusion criteria:
Smoking
Alcohol consumption
Substance abuse
Cardiovascular diseases
Acute and chronic diseases
Prohibition of Dimenhydrinate
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:
15
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 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 (investigator's opinion)
Double blinded
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 .
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 Science
Street address
Babol University of Medical Sciences, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.MUBABOL.REC.1402.018
Health conditions studied
1
Description of health condition studied
Assessment of Cardiac autonomic system responses to oral administration of Dimenhydrinate in healthy subjects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Dr Roghayeh Pourkia
Street address
Rouhani Hospital, Keshavarz Boulevard
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
dr.pourkia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Roghayeh Pourkia
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
dr.pourkia@yahoo.com
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 Roghayeh Pourkia
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
dr.pourkia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Roghayeh Pourki
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
dr.pourkia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Roghayeh Pourkia
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
dr.porkia@yahoo.com
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