Investigation of the efficacy of lettuce seed extract syrup in the treatment of insomnia of cancer patients, a double blind randomized placebo controlled clinical trial
To determine the efficacy and safety of lettuce seed in the treatment of insomnia of cancer patients
Design
Two arm parallel group randomized clinical trial, double blinded
Settings and conduct
Patients with cancer referring to Shohaday-e- Tajrish Hospital of Tehran suffering from insomnia. In order to blind the investigator, medications are named as "A" for syrup of lettuce seeds extract and B for placebo. The patients don't aware of the type of drug she/ he is assigned to. In addition, the groups are entered into statistical analysis as "A" and "B
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Men and women with any type of cancer suffering from insomnia for at least 3 months 2. Patients with Pittsburgh sleep quality index score more than 5*** Exclusion criteria: 1. Diabetic patients 2. Lack of consent to participate in the study 3. Patients with systemic disease (except the cancer) 4.Patients who are taking hypnotic drugs
Intervention groups
Intervention group:Patients of intervention group will receive 5 cc syrup containing 1000 mg of the lettuce seeds extract every night for 2 weeks.*** Control group: Patients of placebo group will receive 5 cc syrup containing 1000 mg starch powder every night for 2 weeks.
Main outcome variables
Quality sleep index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N13
Registration date:2019-08-30, 1398/06/08
Registration timing:retrospective
Last update:2019-08-30, 1398/06/08
Update count:0
Registration date
2019-08-30, 1398/06/08
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-23, 1397/04/02
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2019-06-20, 1398/03/30
Trial completion date
2019-06-20, 1398/03/30
Scientific title
Investigation of the efficacy of lettuce seed extract syrup in the treatment of insomnia of cancer patients, a double blind randomized placebo controlled clinical trial
Public title
Investigation of the efficacy of lettuce seed extract syrup in the treatment of insomnia of cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women with any type of cancer suffering from insomnia for at least 3 months
Patients with Pittsburgh sleep quality index score more than 5
Exclusion criteria:
Diabetic patients
Lack of consent to participate in the study
Patients with systemic disease (except the cancer)
Patients who are taking hypnotic drugs.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization schedule is done by using Random Allocation software and create block randomization table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape and packing of lettuce seed syrup and placebo are similar. Also in this study, the researcher, patient, and statistical analyst will identify the lettuce seed syrup as A and the placebo as B.
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
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.SUMS.REC.1397.417
Health conditions studied
1
Description of health condition studied
insomnia
ICD-10 code
G47.01
ICD-10 code description
Insomnia due to medical condition
Primary outcomes
1
Description
Sleep quality
Timepoint
At the beginning of the study and two weeks after beginning of the study
Method of measurement
Pittsburgh sleep quality index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Patients of intervention group will receive 5 cc syrup containing 1000 mg of the lettuce seeds extract every night for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients of placebo group will receive 5 cc syrup containing 1000 mg starch powder every night for 2 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohay-e-Tahrish Hospital
Full name of responsible person
Dr. Ghazaleh Heydarirad
Street address
Tajrish Square, Shohaday-e-Tejarish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
ghazalrad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younes Ghasemi
Street address
7th floor,Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Dr. Seyed Hamdollah Mosavat
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5646
Email
hamdi_88114@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiraz University of Medical Sciences
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5646
Email
hamdi_88114@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
mmparvizi@gmail.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
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
En Sending Email to the researchers
What processes are involved for a request to access data/document