A clinical study to evaluate Constipation Formulation for treatment of Constipation in Childre
- Conditions
- Health Condition 1: K590- Constipation
- Registration Number
- CTRI/2020/12/030006
- Lead Sponsor
- Amitojas Wellness Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool frequency documented in the CRF at baseline, day 7 and day 14 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline, day 7 and day 14
- Secondary Outcome Measures
Name Time Method Stool consistency documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)Timepoint: baseline, day 7 and day 14;Symptomatic change in abdominal pain documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)Timepoint: baseline, day 7 and day 14;Symptomatic change in fecal incontinence documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)Timepoint: baseline, day 7 and day 14;Weight gained post treatment documented in the CRF baseline, day 7 and day 14 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline, day 7 and day 14