A comparative study of effect of Rosa damascena hydroalcoholic extract and polyethylenglychol in treatment of chronic constipation in children older than one year
In Iranian traditional medicine, Rose is used in the treatment of constipation. In addition to reviewing the available articles, there is no clinical study to confirm the traditional use of this plant in the treatment of constipation. Therefore, the aim of this study was to compare the effect of aqueous-alcoholic extract of rose and polyethylene glycol in the treatment of chronic constipation in children 12 months and up
Design
The study is a randomized clinical trial and is conducted in a children's community with functional constipation. All patients with constipation are selected by Pediatrician by obtaining a biography and are enrolled by parents by obtaining consent. Children were randomly assigned into two groups of study, including the intervention group and the control group. Both the control and intervention groups were interviewed weekly after the administration of the drug in terms of the type and consistency of the stool and in terms of the frequency and convenience of disposal. And re-examination. The study is done blindly and randomly
Settings and conduct
Pediatric Clinic of Yasouj University of Medical Sciences
Participants/Inclusion and exclusion criteria
Children over 12 months of age with chronic constipation with informed consent from parents and lack of underlying illnesses
Intervention groups
1.The control group receiving the usual treatment, polyethylene glycol, receives twice a day (every 12 hours) 0.3 g / kg
2. The test group receiving daily rosacea extract with a daily dose of 0.125 g / kg twice daily (every 12 hours)
Main outcome variables
Changes in patient's bowel habit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151217025575N2
Registration date:2019-07-31, 1398/05/09
Registration timing:retrospective
Last update:2019-07-31, 1398/05/09
Update count:0
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
HOSSEIN SADEGHI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 8944
Email address
hossein.sadeghi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2016-02-01, 1394/11/12
Expected recruitment end date
2017-02-01, 1395/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of effect of Rosa damascena hydroalcoholic extract and polyethylenglychol in treatment of chronic constipation in children older than one year
Public title
Effect of Rosa damascena hydroalcoholic extract and polyethylenglychol in treatment of chronic constipation in childrenr
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 12 months
Lack of underlying illness
Parental Satisfaction to Participate in the Study
Exclusion criteria:
Uncooperative patients
Lack of adequate access to patient
Children with organic reasons of constipation such as Hirschsprung΄s disease, spina bifida occulta, hypothyroidism, chronic intestinal pseudo-obstruction, anorectal abnormalities; history of anorectal/colon surgery; non-retentive fecal incontinency
Taking concomitant medications which could modify bowel habit
Age
From 1 year old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized allocation with simple sampling method to intervention and controlled groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The physician and the evaluator do not have any information about the
Prescribed medication
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences Ethics Committee
Street address
Yasuj University of Medical Sciences, Motahari Boulevard, Yasuj Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2015-11-04, 1394/08/13
Ethics committee reference number
YUMS.REC.1394.97
Health conditions studied
1
Description of health condition studied
Childern with functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Frequency of defication per week
Timepoint
Every three days to three months
Method of measurement
Interviews with parents, Rome 3 standard questionnaire
Secondary outcomes
1
Description
Frequency of bulky solid stool per week and adverse effect
Timepoint
Every three days to three months
Method of measurement
Interviews with parents
Intervention groups
1
Description
Control group: Patients will receive .3 mg/kg poly ethylene glycol for two weeks, if successful it will be continued for three months
ntervention group: Patients will receive .125 mg/kg poly ethylene glycol for two weeks, if successful it will be continu
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Mofateh clinic,Yasuj University of Medical Sciences