Cassia Fistula is a medical plant. Its fruit’s pulp have been claimed to be effective as a laxative. A randomized, case-controlled clinical trial will be conducted to investigate this matter. A total of 72 children of both sexes, aged 4-13 years old, with diagnosed Functional Constipation according to the Rome Ⅲ criteria will be randomized into 2 equal groups of 36 each to receive either 1-4 teaspoons mineral oil or 0.15 g/Kg of aqueous extract of Cassia fistula’s fruit’s pulp (in form of syrup), daily, for three 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 3 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107026932N1
Registration date:2011-08-22, 1390/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-22, 1390/05/31
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
Shahed University (Faculty of Medical Sciences)
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination the efficacy of Cassia Fistula in management of pediatric functional constipation
Public title
Efficacy of Cassia Fistula in constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children between 4 to 13 years old who have at least 2 or more of the followings: Less than 2 defecations 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 are visited by pediatric gastroentrologist to provide complete functional constipation criteria. If the history and physical examination or question is not for functional constipation, ano-rectal manometry is performed
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, Note: 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 4 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Shahed University
Street address
Shahed University, Opposite the shrine of Imam Khomeini (RA), Qom Highway beginning, Tehran
City
Thran
Postal code
3319118651
Approval date
2011-05-31, 1390/03/10
Ethics committee reference number
112251/4
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Number of defications per week
Timepoint
before intervention and 7, 14, 21 days after begining of the intervention
Method of measurement
questionairre
2
Description
Intensity of stiffness of the stool in defication
Timepoint
before intervention and 7, 14, 21 days after begining of the intervention
Method of measurement
questionairre and VAS
3
Description
Intensity of pain of defication
Timepoint
before intervention and 7, 14, 21 days after begining of the intervention
Method of measurement
questionairre and VAS
Secondary outcomes
1
Description
frequency of fecal incontinence per week
Timepoint
before intervention and 7, 14, 21 days after begining of the intervention
Method of measurement
questionaire
2
Description
frequency of fecal soiling per week
Timepoint
before intervention and 7, 14, 21 days after begining of the intervention
Method of measurement
questionairre
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 21 days
Category
Treatment - Drugs
2
Description
Control group: Mineral oil, 1-4 teaspoons, orally, divided in 2 or 3 separated dose, after meals, for 21 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola's Children's Specialized Hospital, Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Street address
Children's Specialized Hospital-Amirkola-Babol
City
Babol
2
Recruitment center
Name of recruitment center
Dr. Esmaeili's office (Pediatric gastroenterologist and professor of Thesis)
Full name of responsible person
Seyyed Ali Mozaffarpur
Street address
upper floor Pasteur Laboratory-
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University - Faculty of Medical Sciences
Full name of responsible person
Dr. Mohsen Naseri
Street address
Shahed University-opposite the shrine of Imam Khomeini (RA)-Qom Highway beginning -Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University - Faculty 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
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
Student of PhD of Traditional Medicine
Other areas of specialty/work
Street address
Group of
City
Tehran
Postal code
Phone
+98 21 8899 6212
Fax
+98 21 8899 6212
Email
seyyedali1357@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University- Faculty of Medical Scienses-Group of Medical Scienses
Full name of responsible person
Dr. Mohsen Naseri
Position
Pharmacologist(MD.PhD)-Associate Professor at the Shahed University