Comparison of the effects of Dracocephalum and Rosa Damascene capsule on sleep disorder in heart failure patients
Design
A clinical trial without a control group, with parallel groups, without blinding, randomized, phase 2, on 80 patients, the eight-block method was used for randomization.
Settings and conduct
People who have heart failure and have referred to medical centers and have sleep disorder according to the Petersburg sleep disorder instrument, are randomly divided into 2 groups if they have informed consent. These two groups have no relationship with each other and at the time of the study, each of the patients only received one of the 2 interventions in addition to the routine treatment, and the output information was provided is measuring by an experienced nurse with a master's degree in internal-surgical nursing who obtained the necessary capabilities.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of heart failure with echo based on EF less than or equal to 40% and confirmation of cardiologist; Having a sleep disorder with a score of 5 or more from the Petersburg sleep disorder instrument despite taking sedatives; Desire and informed consent of the patient
Exclusion criteria: The client's unwillingness to continue cooperation; use of complementary therapies or other drugs affecting sleep concurrently during the study; The occurrence of acute problems leads to changes in the treatment process and the death of the patient
Intervention groups
Patients with heart failure who have sleep disorders and consume Dracocephalum capsules.
Patients with heart failure who have sleep disorders and consume Rosa Damascene capsules.
Main outcome variables
Sleep disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240316061309N1
Registration date:2024-05-17, 1403/02/28
Registration timing:retrospective
Last update:2024-05-17, 1403/02/28
Update count:0
Registration date
2024-05-17, 1403/02/28
Registrant information
Name
Zahra Mahdavi asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5510 3130
Email address
zahramahdaviasl@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Dracocephalum and Rosa Damascene capsule on sleep disorder in heart failure patients
Public title
Comparison of the effects of Dracocephalum and Rosa Damascene capsule on sleep disorder in heart failure patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of heart failure with echo based on EF less than or equal to 40%
confirmation of cardiologist
Having a sleep disorder with a score of 5 or more from the Petersburg sleep disorder instrument despite taking sedatives
Desire and informed consent of the patient
Exclusion criteria:
The client's unwillingness to continue cooperation at any time of the study
use of complementary therapies or other drugs affecting sleep concurrently without coordination during the study
The occurrence of acute problems leads to changes in the treatment process and the death of the patient
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by blocks method, individual randomization, using Sealed Envelope software, by making 10 blocks of 8 patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine and Dentistry - Kashan University of Medical Sciences (Research Ethics Committee
Street address
Qutb Ravandi Blvd- Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.284
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
F51.8
ICD-10 code description
Other sleep disorders not due to a substance or known physiological condition
2
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Sleep disorder
Timepoint
In the pre-intervention period, one day after the first dose, the eighth day after the administration.
Method of measurement
Petersburg Sleep Disorder Questionnaire
Secondary outcomes
1
Description
Anxiety
Timepoint
In the pre-intervention period, one day after the first dose, the eighth day after the administration.
Method of measurement
Spielberger anxiety questionnaire
Intervention groups
1
Description
First intervention group: Recipients of two Dracocephalum plant capsules made by the Health Technology Development Center, Nahal Gostar Chaharmahal Company office, registration number 9927, in one session, for seven days along with the patient's routine medicines
Category
Treatment - Drugs
2
Description
Second intervention group: A large capsule containing 1000 mg of Rosa Damascene by Barij Essence Company, in one dose for seven days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center of Kashan university of medical sciences
Full name of responsible person
Dr. Mohsen Taghadosi
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9392
Email
taghadosi_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. GholamAli Hamidi
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Fax
+98 31 5558 9338
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taghadosi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9392
Email
Taghadosi_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taghadosi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9392
Email
Taghadosi_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Mahdavi Asl
Position
Medical- Surgical M.Sc. Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5510 3130
Fax
Email
zahramahdaviasl@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
At this stage, the goal is to approve the study protocol, and after the completion of the work, the target journal and its results will be adjusted according to the journal protocol (Author's guide) and a decision will be made for publication.
Study Protocol
No - There is not 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
No - There is not 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