The effect of matricaria recutitaon on sleep quality in patients with choronic heart failure
Design
A randomized, triple stage, triple blinded and two-group clinical trial
Settings and conduct
This study is done in Shahid Chamran Hospital in Isfahan. The target group are patients who referred to the center for the treatment of chronic heart failure, and are suffering from at least one sleep disorder. After administering matricaria recutita to the intervention group and placebo for the control group, the patients' sleep quality was assessed by the St. Mary's Hospital Sleep Quality Questionnaire in three stages. The study is triple blind and this is done by two collaborators in the implementation of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 40 to 67 years old; Mild to moderate heart failure; Different degrees of sleep disorders; Not having a physical illness affecting sleep; Do not use drugs that affect sleep
Non-inclusion criteria: History of myocardial infarction in the last three months; significant arrhythmia
Intervention groups
Intervention group 1: Patients take 2 ml of products containing chamomile at a specified hour for one week.
Group 2: Group medication. Patients in this group use the placebo as same as the amount of intervention group 1 at the same time for one week.
Main outcome variables
Patients' sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037895N2
Registration date:2019-05-18, 1398/02/28
Registration timing:retrospective
Last update:2019-05-18, 1398/02/28
Update count:0
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
Mohsen Torabi Khah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3071
Email address
m.torabikhah@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2018-09-22, 1397/06/31
Scientific title
The effect of matricaria recutita drop on sleep quality in patients with choronic heart failure hospitialized
Public title
The effect of matricaria recutita on the quality of sleep
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being aware of time and place
The absence of neurological and psychiatric diseases mentioned in the medical history of the patient
Age 40 to 67 years old
Familiar with Farsi
Mild to moderate heart failure
Ejection fraction between 20 to 40%
Different degrees of sleep disorders include insomnia, delayed sleep, sleep deprivation, sleep disturbance, and overall sleep quality score of over 12, based on St. Mary's Hospital Sleep Quality Questionnaire
Not having a physical illness affecting sleep, such as asthma and thyroid disorders
Do not use drugs that affect sleep such as sedation, housing, antidepressants
No smoking and alcohol
Not having any sensitivity to chamomile and its compounds by means of a questionnaire through a demographic questionnaire on the absence of nausea and vomiting and skin rash following the use of its compounds
Not having sleep apnea
Failure to develop restless leg syndrome
Lack of severe pain and sleep discomfort
Not using complementary medicine in a recent week
Stability of vital signs
Exclusion criteria:
History of heart attack three months ago
Significant arrhythmia
Age
From 40 years old to 67 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Peoples who have inclusion criteria will be randomly assigned into two groups of intervention and control. In this way, 35 cards with number one and 35 cards with number two are enclosed in an envelope, and they are asked to select a card on the day of the random division of the research units. People with number are located in test group, and those with number two are included in control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To eliminate individual factors in the results, the study is done as triple blind. Thus, the samples do not know in which group they are located. Furthermore, two collaborators are hired to do the sampling. In this way, collaborators provide the samples with the medicine and questionnaire. The statistician is not aware of the treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences., Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.039
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
2
Description of health condition studied
Chronic heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention, three days and a week after the intervention
Method of measurement
St. Mary's Hospital Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention receives chamomile drops, called chamazulene (containing a complete extract of chamomile), at 30 drops (about 2 cc), manufactured by Sina Farouor Pharmaceutical Company in Isfahan, in half a glass of water plus half a cube of sugar under the supervision of a doctor before bedtime at midnight in the cardiology department of the hospital for one week.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients are followed up for one week by a doctor. In the same way as a test group, they receive a placebo or a prescriber at the same hour before bedtime. The placebo contains 1.0 cc of the main medicine. This means that there is 1 cc of the main medicine in 10 cc of hydrochemical solution. Moreover, the placebo in terms of color, odor, appearance, and packaging is not different from the original medicine. However, it can be distinguished from the original medicine by the code.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Chamran Hospital
Full name of responsible person
Mohammadreza Shafiei
Street address
Salman-e-farsi
City
Isfahan
Province
Isfehan
Postal code
8158388989
Phone
+98 31 3260 0965
Email
info@chamran.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghaegh Haghjooe Javanmard
Street address
Isfahan University of Medical Sciences, Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673466
Phone
+98 31 3792 7533
Email
sh-haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shahram Rashidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
shahramrashidiesf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Sima Babaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences., Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
babaee@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahram Rashidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
shahramrashidiesf@gmail.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