Management of constipation in children with haritaki khanda

Phase 2

Recruiting

• Conditions: Vibandha (constipation)

• Registration Number: CTRI/2017/03/008095
• Lead Sponsor: Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

Brief Summary

This study is  an open labeled single arm non-randomized prospective clinical trial to study the effect of Haritaki Khanda given at a dose of 6grams bid with warm milk for 14days in children with Vibandha (constipation)and the study will be conducted at Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan  Karnataka India. The primary outcome measures will be relief from constipation and improvements in the diagnostic tool  ROME III criteria for both Neonates and Toddlers and a child with developmental age of 4years and above 4years respectively at 14day and followed for  28 days to assess the sustained effect of trial drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-04
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1 Children either of both genders between the age group of 03 to 06 years.
• 2 Children fulfilling the diagnostic criteria of constipation.
• 3 Parents willing to give assent for the Research study.

Exclusion Criteria

1 Children having constipation secondary to any of other disorder like hypothyroidism, hirschprung’s disease and structural anamolies of anal canal will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in the symptom of Vibandha	14 days
Improvement in the diagnostic tool Rome III criteria	14 days
-for neonates and toddlers --for a child with developmental age of 4 years and above 4 years	14 days

Secondary Outcome Measures

Name	Time	Method
Improvement in overall health and nutrition	Improvement in digestion

Trial Locations

Locations (1)

Dept of kaumarabhritya OPD no 2 Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital; 🇮🇳 Hassan, KARNATAKA, India

Dept of kaumarabhritya OPD no 2 Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital

🇮🇳Hassan, KARNATAKA, India

Dr Sahana CL

Principal investigator

9482645944

sahanavarsha@gmail.com