Protocol summary

Summary
the goal of study is the evaluation of the therapeutic effects of cumin in enuresis in children. Inclusion criteria: 1) Children older than 5 years with enuresis Exclusion criteria: 1) lack of willingness to cooperate during the study 2) reactions to herbal medicine the study will be done in 40 children with enuresis . Patients will divide in two groups, group 1: Desmopressin spray one or two puffs every night in the nose for a month and group 2: oral cumin, 10 drops three times a day for a month the improvement will compare in two group . Improvement means that children less than 2 times a month wet the bed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041533428N1
Registration date: 2017-05-12, 1396/02/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-12, 1396/02/22
Registrant information
Name
Elham Bakhtiari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 3943
Email address
bakhtiarie@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison the therapeutic effects of Cuminum cyminum with desmopressin in children with enuresis
Public title
Cumin effect in the treatment of enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children older than 5 years with enuresis Exclusion criteria: lack of willingness to cooperate during the study; reactions to herbal medicine
Age
From 5 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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
mashhad university of medical sciences
Street address
mashhad, azadi squer
City
mashhad
Postal code
Approval date
2017-01-04, 1395/10/15
Ethics committee reference number
IR.mums.sm.rec.1395.488

Health conditions studied

1

Description of health condition studied
enuresis
ICD-10 code
N32.8
ICD-10 code description
Other specified disorders of bladder

Primary outcomes

1

Description
enuresis
Timepoint
before and one month after intervention
Method of measurement
observation

Secondary outcomes

1

Description
none
Timepoint
none
Method of measurement
none

Intervention groups

1

Description
intervention: cumin drop, 10 drop, three time in day for one month
Category
Treatment - Drugs

2

Description
Control group: desmopressin nasal spray one or two puffs every night for a month
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
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research, mashhad university of medical sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Azadi Squere, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of 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
Mashhad University of Medical Sciences
Full name of responsible person
Anoush Azarfar
Position
Pediatric Nephrology specialists
Other areas of specialty/work
Street address
Dr Sheikh Hospital
City
Mashahd
Postal code
Phone
+98 51 3727 3943
Fax
Email
azarfara@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nephrology Clinic,
Full name of responsible person
Anoush Azarfar
Position
Pediatric Nephrology specialists
Other areas of specialty/work
Street address
Dr Sheikh Hospital
City
Mashhad
Postal code
Phone
+98 51 3727 3943
Fax
Email
Azarfara@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nephrology Clinic
Full name of responsible person
Dr Anoush Azarfar
Position
spacialist medicine
Other areas of specialty/work
Street address
Dr Sheikh Hospital
City
Mashhad
Postal code
Phone
+98 51 3727 3943
Fax
Email
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
Loading...