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The effect of Cassia Fistula in pediatric constipation

Comparison between Cassia Fistula syrup and Poly ethylen glycol in children with functional constipation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201303196932N2
Enrollment
100
Registered
2013-12-04
Start date
2013-04-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation. Constipation (atonic) (simple) (spastic)

Interventions

Intervention 1: 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. Intervention
Treatment - Drugs
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
Control group:PEG, 1 gr/kg/day, orally, divided in 2 separated dose, after meals, for 28 days

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 15 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Number of defications per week. Timepoint: before intervention and 7, 14, 21 ,28 days after begining of the intervention. Method of measurement: questionairre.;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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Ali Mozaffarpur

Babol University of Medical Sciences

seyyedali1357@gmail.com+98 11 1324 6963

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026