1. Study the effect of berry extract in mono symptomatic Nocturnal Enuresis treatment
2. Comparison the effect of berry extract with desmopressin spray in mono symptomatic Nocturnal Enuresis treatment
Design
A non-randomized, non-blinded clinical study without placebo control in phase 2 clinical trial will be conducted.
Seventy children (6-12 years old) with mono-symptomatic Nocturnal ٍEnuresis will be studied in two parallel groups and will be followed for 4 weeks in one clinical center.
Settings and conduct
A non-blinded and non-randomized clinical study will be done on seventy children in two parallel groups with mono symptomatic Nocturnal Enuresis in a clinical center. The berry extract syrup will be administered for one group, While another group will be under treatment by Desmopressin spray. Two groups will be monitored and assessed for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children between 6-12 years old; Satisfied parents for participating in study; Not suffered from incurable and underlying disease; Suffered from mono symptomatic Nocturnal Enuresis
Exclusion criteria: Children out of range 6-12 years old; Lack of permission of parents for participating in study; Suffered from incurable and underlying disease; Not suffered from mono symptomatic Nocturnal Enuresis
Intervention groups
Control group: Desmopressin administration based on medical practitioner order as a treatment of mono symptomatic Nocturnal Enuresis
Intervention group: berry extract syrup (7.5 ml twice a day), is equal to 20 grams of fruit per day
Main outcome variables
Frequency of wet nights in a week
Age of the children
Sexuality of the children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N11
Registration date:2022-09-15, 1401/06/24
Registration timing:registered_while_recruiting
Last update:2022-09-15, 1401/06/24
Update count:0
Registration date
2022-09-15, 1401/06/24
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2022-07-22, 1401/04/31
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the clinical effect of berry extract and comparison with Desmopressin in 6-12 children with primary mono symptomatic nocturnal enuresis
Public title
Comparison the clinical effect of berry extract and Desmopressin in primary mono symptomatic nocturnal enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children between 6-12 years old
Satisfied parents for participating in study.
Not suffered from incurable and underlying disease
Suffered from mono symptomatic nocturnal enuresis
Exclusion criteria:
Children out of range 6-12 years old
Lack of permission of parents for participating in study
Suffered from incurable and underlying disease
Not suffered from mono symptomatic nocturnal enuresis
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Investigation Center of Chronic Kidney Diseases in children
Street address
Children medical clinic, Next to the Imam Khomeini Hospital, Dr Gharib Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2022-04-14, 1401/01/25
Ethics committee reference number
IR.TUMS.CHMC.REC.1401.031
Health conditions studied
1
Description of health condition studied
Mono-symptomatic nocturnal enuresis
ICD-10 code
N39.44
ICD-10 code description
Overflow Reflex Urge incontinence
Primary outcomes
1
Description
Frequency of wet nights in a weekchildren
Timepoint
Before intervention and 4 weeks after beginning the intervention and 2 weeks after cessation of intervention
Method of measurement
Parent’s report in questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Berry hydroalcoholic extract syrup (7.5 ml twice a day), is equal to 20 grams of fruit per day, for 2 consecutive weeks
Category
Treatment - Drugs
2
Description
Cََontrol group: Desmopressin (nasal spray 10 microgram per dose) administration based on medical practitioner order for 4 consecutive weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children medical clinic
Full name of responsible person
Dr. Arash Abbasi
Street address
Children medical clinic, Next to the Imam Khomeini Hospital, Dr Gharib Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 3174
Email
a-abbasi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Vazirian
Street address
Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614315
Phone
+98 21 8889 6696
Email
vazirian_m@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of pharmacognosy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6412 1223
Fax
Email
Vazirian_m@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of pharmacognosy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614315
Phone
+98 21 6412 1223
Fax
Email
vazirian_m@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of pharmacognosy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, 16th Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614315
Phone
+98 21 6412 1223
Fax
Email
vazirian_m@tums.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
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
Demographic specification of patients, would be published, except their names and address. Primary outcome of the patients would be published, too.
When the data will become available and for how long
Data would be available 6 months after publishing the results
To whom data/document is available
Data would be available for researchers in academic and scientific organisations
Under which criteria data/document could be used
Any type of usage of data is allowable, except using for manufacturing a product
From where data/document is obtainable
Sending an E. mail to mehdivazirian@gmail.com
What processes are involved for a request to access data/document
After receiving E. mail, data would be sent within a week