Protocol summary

Summary
This study was an interventional study in a randomized, controlled clinical trial with the aim of effecting nettle (Neonatal Pill) on sleep quality in hemodialysis patients. The statistical population of this study included 90 male and female patients referring to the center of Sari for hemodialysis. The criteria for entering the study include consenting to participate in the research; dialysis treatment at least two times a week, at least 3 months, and 18 years of age and older. Exit criteria also include known psychiatric disorders, diabetes mellitus, urticaria, Myomia or fibroma; menorrhagia; history of gastrointestinal bleeding; mental disorders; heart failure; coronary artery stenosis or myocardial infarction; systolic blood pressure less than 90 mm Hg and substance abuse. Urtica dioica nettle pepper with Netanyon 400 mg brandy. Based on at least 3.1 milligrams of chlorogenic acid in each tablet made from the dried extract of the leaf of the nettle of the nettle plant by Barij Essen, it is used 3 times a day for 3 months in this study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081419677N3
Registration date: 2017-10-30, 1396/08/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-30, 1396/08/08
Registrant information
Name
Ravanbakhsh Esmaeili
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7345
Email address
r.esmaeili@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nettle(Netonal Barij) on sleep quality in hemodialysis patients
Public title
The effect of nettle(Netonal Barij) on sleep quality in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
The criteria for entering the study include consenting to participate in research, dialysis treatment at least two times a week, at least 3 months, and 18 years of age and older. Exit criteria also include known psychiatric disorders, diabetes mellitus, urticaria ; Myomia; menorrhagia; history of gastrointestinal bleeding; mental disorders; heart failure; coronary artery stenosis or myocardial infarction; systolic blood pressure less than 90 mm Hg and substance abuse
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 science,vice chancellor for resea
City
Sari
Postal code
481613445
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.Mazums.Rec.966788

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Quality of Life
Timepoint
end of every month duration 3 month
Method of measurement
pitsburg questionnaire

Secondary outcomes

1

Description
Patients Wellbeing
Timepoint
Every three months
Method of measurement
Questionaire

Intervention groups

1

Description
In the intervention group, nettle tablet
Category
Treatment - Drugs

2

Description
There is no intervention in the control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari Shahrvand Clinic
Full name of responsible person
Khadige Alizade
Street address
Shahrvand Clinic, Keshavarz Bvld, Sari, Mazandaran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi(vicor)
Street address
Vice Chancellor for Research Mazandaran University of Medical Sciences, Moalem Street, Moalem Square, Sari, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences - Faculty of Nursing and Midwifery Nasseibeh
Full name of responsible person
Khadije Alizade
Position
Student of Master of Critical Care Nurses
Other areas of specialty/work
Street address
Nasseibeh Nursing & Midwifery Faculty,vesal Street, Amir Mazandarani Blvd, Sari, Mazandaran
City
Sari
Postal code
4764996893
Phone
+98 11 3325 7230
Fax
Email
Rahaalizade18@outlook.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ravanbakhsh Esmaeili
Position
Assistant Professor
Other areas of specialty/work
Street address
Nasseibeh Nursing & Midwifery Facultry,Vesal Street, Amir Mazandarani Blvd, Sari, Mazandaran
City
Sari
Postal code
Phone
+98 11 3325 7230
Fax
Email
r.esmaeili@mazums.ac
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Khadige Alizade
Position
Student of Master of Critical Care Nurses
Other areas of specialty/work
Street address
Nasseibeh Nursing & Midwifery Facultry, Vesal Street, Amir Mazandarani Blvd, Sari, Mazandaran
City
sari
Postal code
4764996893
Phone
+98 11 3527 9717
Fax
Email
Rahaalizade18@outlook.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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