Evaluation of efficacy and safety of Constipation Formulation in the management of Constipation in Children: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study

Amitojas Wellness Private Limited0 sites0 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•1. Male and female children aged >=3 to <=16 years.
•2. Duration of constipation more than 4 weeks.
•3. Presence of >=2 of the following:
•a. defecation frequency <=2 times per week
•b. faecal incontinence >=1 time per week
•c. history of excessive stool retention
•d. history of painful or hard bowel movements
•e. presence of a large mass in the rectum or on per abdomen examination
•f. history of large-diameter stools that may obstruct the toilet (if information available)
•4. Children willing to provide informed assent if applicable.
•5. Childâ??s parent/guardian/legally acceptable representative willing to provide informed written consent.

•1. Presence of other organic disorders which might be cause of constipation.
•2. Children suffering from irritable bowel syndrome
•3. Children with hormonal diseases
•4. Children who have received other treatments for constipation in the past 48 hours.
•5. Children who are planned to be treated through disimpaction.
•6. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
•7. Allergy or sensitivity to any of the ingredients in the study treatment.
•8. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
•9. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.

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