Determine the effect of coconut oil on mono symptomatic primary enuresis
Design
This interventional study (randomized clinical trial) was randomized and taken into two groups of intervention and control in parallel. Initially, among children with enuresis above the age of 6 years who referred to Shahid Sadughi Hospital and Clinic of Iranian Medicine, randomly and through the delivery of envelopes containing the sample or control And is equal, intervention samples and control are selected. The sample size is 110 people.
Settings and conduct
Shahid Sadoughi Clinic and Clinic of Iranian Medicine
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children with enuresis 6 years of age, lack of medication for complaints two weeks before the start of the study, obtaining consent to enter the study and continue; Possibility of patient following
Exclusion criteria: There are other symptoms of the lower urinary tract, positive urine test for urinary tract infection during the study, presence of hematuria or proteinuria or glucosuria, obvious anatomical and congenital anomalies, a dangerous side effect of taking medication, patient's refusal to continue cooperation, creating an unpredictable problem for each One of the patients
Intervention groups
After entering the study, the patients in the intervention group are treated with coconut oil, with 6 drops of coconut oil in each of the areas of supra pubic, perineal, sacral and flaccid, and each night before bed in these areas by the child's parents Oil is being donated. In the control group, in the same areas, a placebo is used.
Main outcome variables
Enuresis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170423033605N2
Registration date:2018-03-17, 1396/12/26
Registration timing:prospective
Last update:2018-03-17, 1396/12/26
Update count:0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Abolfazl Dehghanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3522 1596
Email address
a.dehghanpoor@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coconut oil on mono symptomatic primary enuresis
Public title
The effect of coconut oil on enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with enuresis 6 years and older
Do not take medication for complaints two weeks before the start of the study
Gain consent to enter the study and continue it
Possibility of patient tracking
Exclusion criteria:
There are other symptoms of the lower urinary tract
Positive urine test for urinary tract infection during the study
Hematuria
Proteinuria
Glucosuria
Anatomical and congenital anomalies
The creation of a dangerous side effect due to drug use
Patient refusal to continue cooperation
Create an unpredictable problem for each patient
Age
From 6 years old to 16 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Through the delivery of envelopes in which they are written as sample or control.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, the main researcher who is also a clinical caregiver and outcome evaluator, were blinded in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Yazd, Shahid Dr. Bahonar Square, Shahid Sadoughi Blvd, Central Office of Yazd Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.SSU.REC.1395.197
Health conditions studied
1
Description of health condition studied
enuresis
ICD-10 code
F98.0
ICD-10 code description
Enuresis (primary)(secondary) of non organic origin
Primary outcomes
1
Description
the frequency of nocturia per week
Timepoint
Before the intervention, 2 weeks, 4 weeks and 8 weeks after the intervention
Method of measurement
Questionnaire on the frequency of nocturia per week
Secondary outcomes
1
Description
age
Timepoint
Before intervention
Method of measurement
questionnaire
2
Description
sex
Timepoint
Before intervention
Method of measurement
questionnaire
3
Description
Complications of intervention
Timepoint
2 weeks, 4 weeks and 6 weeks after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Coconut oil: 6 drops of coconut oil are sacrificed in each of the supra pubic, perineal, sacral and flank areas, and each night before bed, these areas are anointment by the child's parents. Control group: Placebo: In the above areas, a placebo is used to anointment.
Category
Treatment - Drugs
2
Description
Control group: Six placebo drops are sacrificed in each supra pubic, perineal, sacral and analgesic areas and each night before bed, these areas are anointment by the child's parents.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaeipoor Clinic
Full name of responsible person
Dehghanpoor Abolfazl
Street address
Safaieh - Riazi Ave
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3822 9105
Email
A.dehghanpoor@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dehghanpoor Abolfazl
Street address
Imam Khomeini Street, Faculty of Persian Medicine
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
A.Dehghanpoor@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Abolfazl Dehghanpoor
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Clinic of Persian medicine ; Imam Khomeini Street
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
A.Dehghanpoor@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Clinic of Persian Medicine ; Imam Khomeini Street
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
tebsonati@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dehghanpoor Abolfazl
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Clinic of Persian Medicine ; Imam Khomeini Street
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
A.Dehghanpoor@ssu.ac.ir
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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academia
Under which criteria data/document could be used
To promote the level of pediatric's health, especially psychologically
Use of data is conditional on obtaining permission from the original researcher.
From where data/document is obtainable
Dr. Abolfazl Dehghanpour, Iranian Clinic of Medicine, Yazd-Ardakan- Imam Khomeini Ave., Faculty of Iranian Medicine, Postcode: 8951737915
Phone: 035-37238915-18
Email: tebsonati@ssu.ac.ir
What processes are involved for a request to access data/document
Six months after the article was published in one of the ISI journals, the applicant can submit his request by email (at A.dehghanpoor@ssu.ac.ir) and obtain permission to receive the data.