Study of the Effectiveness of Sassurea custos Oil on nocturnal enuresis of pediatric
Design
A randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
Study location: Mofid Hospital
Study Material: In this study 60 children aged 5 to 15 years who were not treated due to nocturnal enuresis and had no renal disease, nervous system disease and urinary tract disease and presented to the project based on the opinion and examination of pediatric nephrology specialist. First, they provide the parents with the necessary information about the research project and after obtaining written consent they will be randomly divided into two groups of control and RCT.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children with a history of enuresis 2 times a week for 3 consecutive months; Age 5 or less than 15 years; Satisfaction with the project; No skin disease in areas intended for drug use; No organ disease associated with enuresis; noninclusion criteria: Frequent urinary tract infection; Previous surgery in the urinary tract; Having daily symptoms such as frequent urination, urinary incontinence; Any chronic degenerative disease involving the nerve or muscle and spinal cord injuries; A history of allergy to vegetable oils
Intervention groups
Intervention group: Sassurea custos Oil
Control group: Sesame oil
Main outcome variables
Percentage of enuresis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190722044304N1
Registration date:2019-09-06, 1398/06/15
Registration timing:prospective
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Mojtaba Bigdeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 5405
Email address
bigdeli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effectiveness of Sassurea custos Oil on nocturnal enuresis of pediatric in Comparison with placebo, A Double-blind Study
Public title
Effectiveness of Sassurea custos Oil on nocturnal enuresis of pediatric
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of enuresis 2 times a week for 3 consecutive months
Ages 5 years or less 15 years
Satisfaction with the project
Lack of skin disease in areas for drug use
No organ disease associated with enuresis
Exclusion criteria:
Frequent urinary tract infection
Previous urinary tract surgery
Have daily symptoms like frequent urination, urinary incontinence
Any chronic degenerative disease involving the nerve or muscle and spinal cord injuries
A history of allergy to vegetable oils
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By throwing a coin, we determine who to give each drug to, and ultimately compare the results of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. The researcher is blind2. The participant is blind
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No, 12, 4 central alley, Alborz St, Ashrafi Esfahani Blvd
City
Tehran
Province
Tehran
Postal code
1477765666
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SBMU.REC.1398.012
Health conditions studied
1
Description of health condition studied
Children's enuresis
ICD-10 code
F98.0
ICD-10 code description
Enuresis not due to a substance or known physiological condition
Primary outcomes
1
Description
Percentage of enuresis
Timepoint
At the beginning of the study one month later
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The consumable material is the Costus; Its chemical composition is Dehydrocostus; The dose is 20 drops twice daily for one month; Local ,on the bladder; Costus oil made by Department of Pharmacology, Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Category
Treatment - Other
2
Description
Topical chemical sesame oil Linoleic acid and 20 drops twice daily topical use