Health Condition 1: K590- Constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Duration of more than 4 weeks for all ages . Presence of >=2 of the following : 1) Defecation frequency 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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency per weekTimepoint: over the 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Stool consistency ( According to Bristol stool chart , Type 3 and beyond ) 2)Frequency of pain or difficulty in passing stools (no of episodes per week ) 3)Frequency of soiling episodes (no. of episodes per week) 4)Compliance with the preparation ( 80% of the prescribed dose) 5)side effects like nausea,diarrhea , abdominal pain 6)use of any rescue therapyTimepoint: over the 24 weeks of treatment | — |
Countries
India
Contacts
Eras Lucknow Medical College