The R-R intervals in the ECG are not similar if it is measured by the variation beat-to-beat, a phenomenon which is known as heart rate variability (HRV). The attenuation of the HRV criteria in some diseases, the elderly, and even in the general population can predict of sudden cardiac events and mortality. Each factor reducing HRV criteria is known a risk factor of cardiovascular events. Evidence shows the potential impact of Eucalyptus plant in autonomic nervous system. The aim of this study is to evaluate the effect of acute consumption of eucalyptus soft capsules (200 mg; Barij Essence Pharmaceutical Co.) on the physiological function of the heart (till 2 hours after consumption) by measurement of frequency and time domain of HRV indexes. The design of this study determines that each subject (of the total subjects n=15) has to attend in the ECG recording lab two sessions with a week interval to randomly receive the drug or placebo. In each session before and after administration of drug or placebo, ECG lead II continuously is recorded for five min in supine position. Then, time and frequency domains of HRV criteria are calculated. The inclusion criteria are being female and age of 19 to 24 and the exclusion criteria are chronic diseases (such as diabetes, hypertension, epilepsy, etc.), smokers, and chronic medication consumers. The interventions of the study include the single dose of soft capsules eucalyptus. The mean and standard deviation of sequential R-R intervals are the primary outcomes of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016032911236N6
Registration date:2016-12-08, 1395/09/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Esmaeil Akbari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 12 1223 0855
Email address
akbari_esmaeil@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-01-10, 1395/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect single dose of eucalyptus soft capsule on heart rate variability criteria in healthy subjects
Public title
The effect of oral Eucalyptus on heart rate variability
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: female; ages between 19-24 years old. Exclusion criteria: chronic disease (i.e. diabetes mellitus, hypertension, epilepsy and etc); smoking; under regular medication
Age
From 19 years old to 24 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
941310
Health conditions studied
1
Description of health condition studied
Healthy subjects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mean of RR interval
Timepoint
before and after administration of placebo or drug
Method of measurement
Time domain analysis of ECG
2
Description
Standard deviation of RR interval
Timepoint
before and after administration of placebo or drug
Method of measurement
Time domain analysis of ECG
Secondary outcomes
1
Description
High frequency power spectrum (a quantity index of cardiac vagal function)
Timepoint
before and after administration of placebo or drug
Method of measurement
Frequency domain analysis of ECG
2
Description
Low frequency power spectrum
Timepoint
before and after administration of placebo or drug
Method of measurement
Frequency domain analysis of ECG
Intervention groups
1
Description
Oral administration of placebo.
Category
Placebo
2
Description
Oral administration of 200 mg soft capsule of Eucalyptus
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Medicine, Mazandaran University of Medical Sciences
Full name of responsible person
Esmaeil Akbari
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Deputy, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad-ali Enayati
Street address
Research and Technology Deput, Moalem Square, Buil. No 2, Mazandaran University of Medical Sciences, Sari, Iran.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Deputy, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran Sari