Evaluation of the possible hypnotic impact of Brassica oleracea product in patients with insomnia
Design
Randomized clinical trial using cards lottery method, two parallel intervention and control groups, 86 patients (43 people in each group)
Settings and conduct
This clinical trial will be performed on 86 patients aged 18 to 60 who suffer from a sleep disorder. Patients are randomly divided into three groups of 43, the first group receiving 1 capsule of a placebo, and the second group receiving 1 capsule of the extract every day for 4 weeks. The sleep quality of both groups was measured by Pittsburgh standard sleep quality questionnaire before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient 18 to 60 years old; Sleep problems in recent weeks, with no history of allergic reactions to red cabbage or its derivatives. Exclusion criteria: History of any mental disorder, failure to return for evaluation at the end of the course
Intervention groups
Group 1: recipients of placebo capsules. Group 2: recipients of red cabbage extract capsules.
Main outcome variables
Change of score in the Petersburg Questionnaire before the start of the study and at the end of the study based on the Petersburg Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190406043175N9
Registration date:2023-07-09, 1402/04/18
Registration timing:prospective
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
fatemeh forouzanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 7318
Email address
forouzanfarf@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the possible hypnotic impact of Brassica oleracea product in patients with insomnia
Public title
The effect of red cabbage on insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-pregnant men and women 18 years or older
Sleeping problem in recent weeks
No history of allergic reactions to red cabbage or its derivatives
Having enough literacy to read and understand the questionnaire and answer the questions alone
Exclusion criteria:
History of any mental disorder
History of serious cardiovascular, liver, kidney or other systemic diseases
History of addiction or smoking
History of abnormal thyroid function tests
History of taking anti-depressant or anti-psychotic drugs two weeks before entering the study
Occurrence of allergic reactions to the capsules and their contents during the study period
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The numbers from 1 to 86 are written on 86 papers and placed inside a bag. Even numbers are for intervention group and odd numbers are for control group. Each time a patient enters the study according to entry criteria, a paper is removed from the bag and the number written on the paper is the base of entering to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Healthcare personnel, data collection authorities and those who evaluate the outcome are completely uninformed about the recipient groups. It should be noted that the patient is aware of the clinical trial but does not know whether he is taking the placebo or the main drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-12-20, 1401/09/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.595
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia
Primary outcomes
1
Description
Change of score in the Pittsburgh questionnaire
Timepoint
Before the start of the study and at the end of the study
Method of measurement
Based on the Pittsburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Receiving the same form of capsule prepared from red cobbage extract with starch powder without red cobbage in the unique shapes for all groups. It is noteworthy that these capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 4 weeks. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug.
Category
Treatment - Drugs
2
Description
Intervention group: Receiving the capsule prepared from red cobbage extract with starch powder in form of unique shapes for all groups. These capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 4 weeks. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Forouzanfar
Street address
Mashhad University of Medical Science, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
forouzanfarf@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Deputy of Research and Technology, Ghorashi Building, next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Forouzanfar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2538
Email
forouzanfarf@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Forouzanfar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2538
Email
forouzanfarf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Forouzanfar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
forouzanfarf@mums.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