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Constipation Relieving Herbal Syrup for Children aged 3 to 12 years.

Not Applicable
Conditions
Health Condition 1: K590- Constipation
Registration Number
CTRI/2019/08/020576
Lead Sponsor
The Himalaya Drug Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Paediatric subjects aged between >=3 years to <= 12 years.

2. Pediatric subjects clinically diagnosed with Functional Constipation as per ROME III criteria.

3. Parents/caregivers willing to consent for the participation of their child.

4. Child >= 7 years willing to assent for its participation in the study.

Exclusion Criteria

1. Pediatric subjects with any clinically significant systemic illness requiring long term medication.

2. A known history or present condition of allergic response to products its components or to any of the ingredients in the test product

3. Pediatric Subjects treated with any laxatives, 2 weeks prior to screening and are experiencing the laxative effect.

4. Pediatric Subjects on any drugs which can induce constipation especially opioid induced constipation (OIC) will be excluded

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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