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Comparative study of Homeopathic and Conventional treatment in childre

Phase 3
Active, not recruiting
Registration Number
CTRI/2018/09/015641
Lead Sponsor
CCRH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Male or female singleton children born to women in good general health with institutional delivery at weeks 37 to 42.

2.Signed and dated informed consent from both parents.

3. Parents willing and able to comply with all study procedures, and be available for the duration of the study.

Exclusion Criteria

1. Children with severe congenital malformation adversely affecting life expectancy or neurodevelopment

2. Children with major malformations, hydrocephalus, chromosomal

abnormalities, hydrops fetalis.

3. Congenital infections.

4. Children born to women with conditions such as HIV and self-reported hepatitis B and/or C infection.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison of the sum of sick days during the first 24 months of life <br/ ><br>between children receiving homeopathic and conventional treatment. Sick <br/ ><br>days will be defined as any illness in which body temperature (measured by <br/ ><br>digital thermometer in the ear canal) is above 37.5°C, and/or any condition <br/ ><br>defined as acute by the treating doctor (in cases of conditions without fever).Timepoint: 3,6,9,12,15,18,21 and 24 MONTHS
Secondary Outcome Measures
NameTimeMethod
1. Comparison of the following between children treated conventionally and homeopathically during the first 24 months of life: <br/ ><br>-cognitive and motor development of children assessed by the DASII and CDC Milestone Tracker. <br/ ><br>-anthropometry measures <br/ ><br>-occurrence and evolution of diarrhoeas <br/ ><br>-occurrence and evolution of respiratory infections. <br/ ><br>2. Comparison of mortality between two groups <br/ ><br>3.Comparison of cost between two groups <br/ ><br>Timepoint: 3,6,9,12,15,18,21 and 24 MONTHS
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