Protocol summary

Study aim
The effect of lettuce seed oil on insomnia during pregnancy and evaluation of melatonin level before and after intervention
Design
clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 90 patients
Settings and conduct
Both groups will also request to fill in a questionnaire. Before start of treatment the patients will be ask to collect a first morning urine sample . At the end of treatment again patients will ask to collect a first morning urine sample and also refuel sleep questionnaire and efficacy drug will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with aged between 20-45 years. Gestational aged between 26 and 32weeks Women with Pittsburgh sleep quality index score more than 5. Exclusion criteria: Patients who don't have suffer from insomnia before pregnancy. high risk pregnancy (multiple pregnancy, threated abortion, preeclampsia, …) Patients who don't have contraindication of doing exercise during pregnancy.
Intervention groups
Intervention group: 45 patients will be treated by lettuce seed oil twice daily from beginning of study within 2 weeks. control group: will be received placebo manufactured by Shiraz pharmacy school with the same method.
Main outcome variables
Finally, urinary melatonin levels are compared before and after treatment and the effectiveness of this treatment is evaluated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140525017827N7
Registration date: 2019-10-22, 1398/07/30
Registration timing: prospective

Last update: 2019-10-22, 1398/07/30
Update count: 0
Registration date
2019-10-22, 1398/07/30
Registrant information
Name
Nasrin Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
asadin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lettuce seed oil extract on treatment of insomnia in pregnant women and study of urinary melatonin before and after taking
Public title
The effect of lettuce seed oil on insomnia in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with aged between 20-45 years Gestational aged between 23-26 weeks with Pittsburgh sleep quality index score more than 5
Exclusion criteria:
Patient must not have been taking hypnotic drug Interventions and outcomeshigh risk pregnancy (Multiple pregnancy, gestational diabetes mellitus, hypertension, preeclampsia, .....) patients must not have suffered from insomnia before pregnancy patients must not have been treated by LS oil within the preceding year patient must not have been taking hypnotic drug
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use similar bottles
Blinding (investigator's opinion)
Double blinded
Blinding description
lettuce seed oil and placebo have been administered in the similar bottles, so patients and researchers were unable to detect which one was Pentoxifiylline or placebo. Our nurse colleague in this study in Hafez hospital delivered formulations to the participants of the study according to the randomized block table. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.SUMS.MED.REC.1398.164

Health conditions studied

1

Description of health condition studied
Nonorganic insomnia
ICD-10 code
F51.0
ICD-10 code description
maternal disorders predominantly related to pregnancy

Primary outcomes

1

Description
Measurment of urine Melatonine
Timepoint
Before and after treatment
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: lettuce seed oil twice daily for 14 days
Category
Treatment - Drugs

2

Description
Control group: Placebo twice a day for 14 days made by the Faculty of Pharmacy of Shiraz university of medical sciences.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Amolbanin Hassani
Street address
Hafez Clinic, Chamran blvd
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
banin.hassani5349@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yoones Ghasemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Omolbanin Hassani
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
banin.hassani5349@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology) research center, Hafez Hospital, Chamran Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
nasadi2012@yahoo.ca

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology) research center, Hafez Hospital, Chamran Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
nasadi2012@yahoo.ca

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2019 Ethic form: 2019
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document
IPD: Vice chancellery Ethic form: Vice chancellery
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