The purpose of this study is to evaluate the hypnotic effect of lettuce seeds (Lactuca sativa L.) in insomnia patients in a double-blind clinical trial.
Design
Clinical trial of phase 2-3 with control and intervention groups, with parallel groups, double blind, randomized
Settings and conduct
This clinical trial will be performed on 60 patients with primary sleep disorder. Patients are randomly divided into two groups of 30 each, that the patients are randomly assigned to a bottle containing placebo or herbal syrup. The unique codes make by the software are used on drug boxes. In addition to the first visit, patients will be visited at the end of the fourth week after receiving the medication. Sleep quality in both groups will be measured before and after the intervention using the standard Pittsburgh Sleep Quality Questionnaire. This questionnaire is designed to assess individuals' sleep quality and includes seven questions.These items are scored on a scale of 0 to 3 by the subjects studied, resulting in scores of 0 to 21. Higher scores are considered as worse sleep quality.
Participants/Inclusion and exclusion criteria
People aged 20 to 50 years who have a history of primary insomnia disorder (people with this disorder have difficulty starting and maintaining sleep and feel tired and restless after waking up) will be included in the study.
Patients with a history of secondary insomnia disorder, such as insomnia due to medication use, or sleep disorder related to another mental disorder will not be included in the study.
Intervention groups
Patients were randomly divided into two groups of 30 each, with one group receiving lettuce syrup and the other receiving placebo for four weeks each night. Two groups will receive routine insomnia medications during the study.
Hypnotic effect of Lactuca sativa seed in patients with insomnia: a randomized double-blind clinical trial
Public title
Hypnotic effect of Lactuca sativa seed in patients with insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People 20 to 50 years
History of Primary Insomnia Disorder (People with sleep disorders have difficulty starting and maintaining sleep and feel tired and restless after waking up. Their daily functioning decrease and they are constantly thinking of having a restful sleep.
The women in the study had a negative pregnancy test and had appropriate prevention methods during the study.
No history of asthma and heart disease (heart block and heart failure)
Patients should not use analgesic drugs regularly for any reason
Exclusion criteria:
A history of secondary insomnia disorder, such as insomnia from medication use, or sleep disorder related to another mental disorder
Pregnancy and Lactation
History of heart, kidney or liver disease
History of neurological and neurological diseases
History of diabetes
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com)
Blinding (investigator's opinion)
Double blinded
Blinding description
Unique codes, which is generated by the software, will be used on the drug and placebo boxes. By entering each individual into the study based on the produced sequence, the drug or placebo box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences,
Street address
Ahvaz Jundishapur University of Medical Sciences,, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
-61357-15794
Approval date
2019-07-19, 1398/04/28
Ethics committee reference number
IR.AJUMS.REC.1398.424
Health conditions studied
1
Description of health condition studied
Primary insomnia
ICD-10 code
F51.01
ICD-10 code description
Primary insomnia
Primary outcomes
1
Description
subjective sleep quality
Timepoint
In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Sleep Time
Timepoint
In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication
Method of measurement
Pittsburgh Sleep Quality Questionnaire
3
Description
Sleep Duration
Timepoint
In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication
Method of measurement
Pittsburgh Sleep Quality Questionnaire
4
Description
daytime dysfunction
Timepoint
In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
1
Description
The rate of drug side effects
Timepoint
During drug use
Method of measurement
Patient Report
Intervention groups
1
Description
Intervention group: They will receive 15 ml of lettuce seed syrup that will be made by the researchers of the present Project, every night for four weeks. Each 15 ml of syrup contains 100 mg total phenols as gallic acid equivalents. The intervention group will receive their routine insomnia medications during the study.
Category
Treatment - Drugs
2
Description
Control group: They will receive placebo syrup every night for four weeks.The control group will receive their routine insomnia medications during the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical office
Full name of responsible person
Alireza Hassanzadeh
Street address
kianpars street
City
Ahvaz
Province
Khouzestan
Postal code
6155955634
Phone
+98 61 3391 5899
Email
golfakhrabadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 2414
Email
Badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data will be shared
When the data will become available and for how long
The access time is up to 6 months after the results are published
To whom data/document is available
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.
Under which criteria data/document could be used
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.
From where data/document is obtainable
Applicants can email the responsible author to receive the requested data
What processes are involved for a request to access data/document
Applicants will have access to the data from the present study by emailing the responsible author for up to one month.