Objectives: Determination the efficacy of rose petals on improving enuresis and comparison with pharmacological therapy (desmopressin) in children.
Methods: In this study, the informed consent form will be given to all patients with nocturia. Then patients will be enrolled to complete the form. The patients are divided into two groups, one group of desmopressin nasal spray one or two puffs every night for a month in the second group with rose petals (Glqnd- potion Barij Essence) 1 teaspoon 3 times a day half an hour after a meal can be treated and these two methods are compared with each other. SPSS was used to analyze the data SPSS software
Terms of arrival and departure:
Inclusion criteria: children younger than 5 years of age with enuresis
Exclusion criteria: unwillingness to cooperate during the study, the incidence of allergy to the drug product, diabetes, kidney stones, urinary tract disorders and thalassemia
Interventions: use of rose petals to treat enuresis
The main outcome variables: the improvement of nocturia as defined recovery times of wet nights less than 3 times a month is called. Primary nocturnal enuresis means bedwetting continues to ages of children waiting for bladder control goes without children at least one year, consecutive dry nights (recovery) is experienced
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050233653N2
Registration date:2017-05-31, 1396/03/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Ramin Sargazi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8299
Email address
sargazir901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-06-21, 1396/03/31
Expected recruitment end date
2018-01-30, 1396/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rose petals (Rosa Damascena) with the drug desmopressin in children with enuresis
Public title
Effect of leaf flowers on enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children younger than 5 years of age with enuresis
Exclusion criteria: unwillingness to cooperate during the study; the incidence of allergy to the drug product; diabetes; kidney stones; urinary tract disorders and thalassemia
Age
From 5 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
none
Secondary trial Id
0000
Registration date
2017-11-22, 1396/09/01
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Mashhad University of Medical Sciences
Street address
Azadi Square; Mashhad
City
Mashhad
Postal code
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.MUMS.SM.REC.1395.633
Health conditions studied
1
Description of health condition studied
enuresis
ICD-10 code
R32
ICD-10 code description
A disorder characterized by involuntary voiding of urine, by day and by night, which is abnormal in relation to the individual's mental age, and which is not a consequence of a lack of bladder control due to any neurological disorder, to epileptic attacks
Primary outcomes
1
Description
enuresis
Timepoint
A month after intervention
Method of measurement
Read wet nights less than 3 times a month
Secondary outcomes
1
Description
Reactions to medicinal products
Timepoint
Any time during the study
Method of measurement
Symptoms of drug allergy
Intervention groups
1
Description
Control group: the use of desmopressin nasal spray one or two puffs every night for a month
Category
Treatment - Drugs
2
Description
Intervention group : Use 1 teaspoon of Rosa Damascena, 1 times a day, half an hour after dinner and before bedtime
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology Clinic of Dr Sheikh Hospital
Full name of responsible person
Dr. Anoush Azarfar
Street address
Dr. Sheikh hospital, Gharani BLV,Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Anush Azarfar
Street address
The headquarters of Mashhad University of Medical Sciences, University streets
City
Mashhad
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, Mashhad 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
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Anosh Azarfar
Position
Pediatric Nephrologist
Other areas of specialty/work
Street address
Dr Sheikh Hospital, Gharani BLV, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
azarfara@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Anush Azarfar
Position
Pediatric Nephrologist
Other areas of specialty/work
Street address
Dr Sheikh Hospital, Gharani BLV, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
azarfara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Anush Azarfar
Position
Pediatric Nephrologist
Other areas of specialty/work
Street address
Dr Sheikh Hospital, Gharani BLV, Mashhad ،
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
azarfara@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)