Effect of Balachaturbhadra Churna & Arvindasava in the Management of Jeerna Balatisara (Chronic Non Specific Diarrhoea in Children)

Phase 2

Conditions: Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified

Registration Number: CTRI/2019/07/019997

Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients of either sex with age between 3 to 5 years

2.Patients of Non Specific Chronic diarrhea fulfilling Rome IV criteria, which is as follows:

a)Passage of large unformed stools, three or more times a day, daily, painless for more than 4 weeks.

b)Onset of symptoms begins between 6 and 60 months of age.

c)Passage of stools occurs during waking hours.

d)There is no failure to thrive, if caloric intake is adequate.

3.Willing and able to participate (consent to be obtained from Parent(s) / Guardian(s)/ Assent from children wherever possible).

Exclusion Criteria

1.Known case of acute diarrhea (history < 2 weeks) and Infectious Diarrhea (confirmed by laboratory investigation).

2.Patients with bleeding per rectum.

3.Patients suffering from any systemic illness affecting the bowel habits.

4.Children with abnormal laboratory values at admission in to the study: serum creatinine > 0.7 (mg/dl); AST >25(U/L); ALT >29(U/L) ; Alkaline phosphatase > 391 (U/L) and any other condition which the investigator thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in frequency of stools. <br/ ><br> <br/ ><br>2.Changes in consistency of stools assessed by using Bristol stool chart.Timepoint: Base line <br/ ><br>7th Day <br/ ><br>14th Day

Secondary Outcome Measures