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Comparison of Effect of Noma Syrup (Lactuca sativa leaf extract) with Clonazepam Tablet on Insomnia Severity in Hemodialysis Patients

Protocol summary

Study aim
Determining the effect of Noma syrup (Lactuca sativa leaf extract) with clonazepam tablets on the severity of insomnia in hemodialysis patients.
Design
Clinical trial with control group, 102 patients were randomly assigned to two groups of 51 patients receiving Noma syrup and control (receiving clonazepam tablets) according to the computer program Permuted Block Randomization.
Settings and conduct
intervention group drink Noma syrup containing 240 ml every night for 20 ml, half an hour before bedtime for two weeks. The drug in the control group is clonazepam tablets, which will be given 0.5 mg of clonazepam tablets every night, half an hour before bedtime, for two weeks to the subjects in the control group. The severity of insomnia with the ISI index is completed before the start of the study and after two weeks of medication. The place of study is the Shahrvand center of Sari city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People 18 years and older with insomnia problem, hemodialysis two or three times a week, Iranian nationality, mental alertness, ability to answer questions, no delirium, no cognitive problems, no history of stroke and Incurable diseases such as cancer, no severe hearing and vision problems and substance abuse. Exclusion criteria: Patients taking anti-anxiety or hypnotic drugs. Patients using accompanying therapies such as acupuncture, herbal remedies, hypnosis or yoga. The patient's unwillingness to continue the study, exacerbation of sleep disorders, delirium, allergic reaction or death of the patient are the exclusion criteria.
Intervention groups
In the intervention group, Noma syrup is consumed 20 ml every night, 30 minute before going to bed for two weeks. In the control group, clonazepam tablets will be given 0.5 mg of clonazepam tablets every night, 30 minute before bedtime, for two weeks.
Main outcome variables
Insomnia Severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110906007494N37
Registration date: 2021-06-22, 1400/04/01
Registration timing: prospective

Last update: 2021-06-22, 1400/04/01
Update count: 0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect of Noma Syrup (Lactuca sativa leaf extract) with Clonazepam Tablet on Insomnia Severity in Hemodialysis Patients
Public title
The Effect of Noma syrup on insomnia in hemodialysis patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People 18 years and older with insomnia hemodialysis two or three times a week Iranian nationality mental alertness and ability to answer questions lack of delirium (Delirium Screening Nursing Scale (NE-DESC)) Lack Existence of cognitive problems (examination by MMSE test) no history of stroke Lack of incurable diseases such as cancer Absence of severe hearing and vision problems No substance abuse
Exclusion criteria:
Patients taking anti-anxiety or hypnotic drugs due to neuropsychiatric disorders Patients using combination therapies such as acupuncture, herbal remedies, hypnosis or yoga The patient's unwillingness to continue participating in the study Exacerbation of sleep disorder Delirium incidence Allergic reaction or death of the patient
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals are randomly assigned to two groups of 51 intervention and control using random numbers provided by computer software and Permuted Block Randomization by a statistical consultant. 25 blocks of 4 and one block of 2 so that in blocks of 4, two people from the intervention group and two people from the control group and in the block of two, one person from the intervention group and one person from the control group . Therefore, 102 envelopes are designed and the letter A (intervention group) and the letter B (control group) are embedded in it based on the information obtained from the computer program. Envelopes are numbered from one to 102. Respectively, the first patient who is admitted to the ward and has the inclusion criteria enters the study after obtaining informed written consent and sampling continues until patient number 102.
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.MAZUMS.REC.1400.245

Health conditions studied

1

Description of health condition studied
Insomnia severity
ICD-10 code
G47.00
ICD-10 code description
Insomnia, unspecified

Primary outcomes

1

Description
Insomnia Severity
Timepoint
Before the intervention and after the intervention
Method of measurement
Insomnia Intensity Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Noma syrup containing 240 ml of processed lettuce leaf extract is consumed 20 ml every night, half an hour before going to bed for two weeks.
Category
Treatment - Drugs

2

Description
Control group: Clonazepam tablets will be given half a mg each night, half an hour before bedtime, for two weeks to subjects in the control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized clinic of Shahrvand Kidney Patients Center
Full name of responsible person
Arash Azad Farzin
Street address
Mazandaran University of Medical Sciences ,valiye asr highway, Joybar 3way ,Imam Sq,Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
arashazad1986@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Mazandaran University of Medical Sciences ,valiye asr highway, Joybar 3way ,Imam Sq,Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3397 8055
Email
arashazad1986@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Reseach Assistant of Mazandaran University of Medical sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3379 5508
Email
arashazad1986@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences,three way Joibar,highway basij,imam square,Sari,Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
Anna3043@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty, Sari
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
Anna3043@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
There is no more informatio
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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