Comparison of Polyethylene glycol 3350 and 4000 in children with chronic constipatio
- Conditions
- Health Condition 1: K590- Constipation
- Registration Number
- CTRI/2022/04/041995
- Lead Sponsor
- Dr SNIGDHA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Duration of more than 4 weeks for all ages .
Presence of >=2 of the following :
1) Defecation frequency <=2 times per week
2) Fecal incontinence >=1 times per week after the acquisition of toileting skills ,
3) history of excessive stool retention ( retentive posture, stool witholding behaviour)
4) history of painful or hard bowel movements ,
5) presence of a large mass in the rectum or on per abdomen examination
6) history of large diameter stools that may obstruct the toilet.
(Based on History , Physical Examination and Exclusion of Red Flags)
1) Motility related disorders -Hirschprung disease
2) Congenital anomalies -Anal stenosis , anteriorly displaced Anus,spinal cord anomalies( tethered cord , spina bifida)
3) Devlopmental defect -mental retardation , autism OR cerebral palsy
4) use of PEG with 2 months before inclusion or concurrent use of other drugs influencing gastrointestinal motility -opiates, anticholinergic agents,phenobarbitone,vincristine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool frequency per weekTimepoint: over the 24 weeks of treatment
- Secondary Outcome Measures
Name Time Method 1)Stool consistency ( According to Bristol stool chart , Type 3 and beyond ) <br/ ><br>2)Frequency of pain or difficulty in passing stools <br/ ><br>(no of episodes per week ) <br/ ><br>3)Frequency of soiling episodes (no. of episodes per week) <br/ ><br>4)Compliance with the preparation ( 80% of the prescribed dose) <br/ ><br>5)side effects like nausea,diarrhea , abdominal pain <br/ ><br>6)use of any rescue therapyTimepoint: over the 24 weeks of treatment