Cassia Fistula is a medical plant. Its fruit’s pulp have been claimed to be effective as a laxative. Previously, we conducted a randomized, placebo-controlled clinical trial in 81 children with functional constipation and compared cassia fistula with Mineral oil within 3 weeks medication. In this study we want to conduct another research in 100 children of both sexes, aged 2-15 years old, with diagnosed Functional Constipation according to the Rome Ⅲ criteria. they will be randomized into 2 equal groups of 50. 1 g/kg/d Poly Ethylen Glycol (pydrolax) were given in one group and 0.15 g/Kg of aqueous extract of Cassia fistula’s fruit’s pulp (in form of syrup), daily in another group, for 4 weeks. Number of defecation in the toilet per week, intensity of pain during defecation, and stiffness of stool (by Visual Analog Scale) will be compared between groups after 4 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303196932N2
Registration date:2013-12-04, 1392/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Seyyed Ali Mozaffarpur
Name of organization / entity
Babol University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9936
Email address
seyyedali1357@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Cassia Fistula syrup and Poly ethylen glycol in children with functional constipation
Public title
The effect of Cassia Fistula in pediatric constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children between 2 to 15 years old who have at least 2 or more of the followings: Less than 2 defections in the toilet each week: More than 1 episode of fecal incontinence per week; History of retentive posturing or excessive volitional stool retention; History of painful or hard bowel movements; Presence of a large fecal mass in the rectum; History of large diameter stools that may obstruct the toilet; children with inclusion criteria will be seen by a pediatric gastroenterologist to provide complete functional constipation criteria. If the history and physical examination, functional constipation is not proved or questioned, anorectal manometry is performed.If confirmed in functional constipation and the tendency of parents, children are enrolled.
Exclusion criteria: any symptom of organic constipation in the history or physical examination; any evidence of organic constipation in anorectal manometry; fecal impaction on physical examination that cannot be removed; presence of other chronic diseases that lead to long-term use of drugs; Long-term consumption of drugs that can cause constipation; intolerance of drinking cassia syrup (nausea and vomiting or severe abdominal pain or allergic symptoms); no compliance, the patient's unwillingness to continue treatment; If any complication due to drugs (such as crampy abdominal pain; probable electrolyte disorder signs due to severe diarrhea (potassium imbalance); muscle weakness or palpitation;and facial and limbs edema; or other complications that are possibly related to drugs) happen, the treatment will be discontinued the adverse effect are recorded.
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences
City
Babol
Postal code
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
30/3326/ژ/پ
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation (atonic) (simple) (spastic)
Primary outcomes
1
Description
Number of defications per week
Timepoint
before intervention and 7, 14, 21 ,28 days after begining of the intervention
Method of measurement
questionairre
2
Description
Intensity of pain of defication
Timepoint
before intervention and 7, 14, 21,28 days after begining of the intervention
Method of measurement
questionairre and VAS
3
Description
Intensity of stiffness of the stool in defication
Timepoint
before intervention and 7, 14, 21,28 days after begining of the intervention
Method of measurement
questionairre and VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aqueous extract of Cassia fistula’s fruit’s pulp (in form of syrup), 0.15 g/Kg/day, orally, divided in 2 or 3 separated dose, after meals, for 28 days
Category
Treatment - Drugs
2
Description
Control group:PEG, 1 gr/kg/day, orally, divided in 2 separated dose, after meals, for 28 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Non-Communicable Pediatric Diseases Research Center, Amirkola children’s hospital
Full name of responsible person
Mohaddese Mirzapour
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Amirkola children’s hospital, Amirkola.
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Amrollah Mostafazade
Street address
Babol University of Medical Sciences, Deputy of Research and Technology
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
PHD of traditional medicine / Head of the faculty of Traditional Medicine
Other areas of specialty/work
Street address
faculty of traditional medicine, Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1324 6963
Fax
Email
seyyedali1357@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
PHD of traditional medicine
Other areas of specialty/work
Street address
traditional medicine department, Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1324 6963
Fax
Email
seyyedali1357@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
PHD of traditional medicine / Head of the faculty of Traditional Medicine
Other areas of specialty/work
Street address
faculty of traditional medicine,Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1324 6693
Fax
Email
seyyedali1357@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)