Clinical study to evaluate efficacy of Dabur Chyawanjunior in comparison with Bournvita in overallgrowth of primary school going childre

Not Applicable

Completed

• Registration Number: CTRI/2017/08/009320
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-05-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

1. Male & female children with age not more than 12 years.

2. Medically stable with no requirement of drugs,or any interventions/procedures or any neutraceutical / health supplement.

3. Permission was obtained from the parents of all children and willing to sign an informed consent.

4. Parents and teacher of the child willing to sign an informed consent

Exclusion Criteria

1. Children with any underlying physical or mental illness.

2. Children who required use of concomitant medications known to adversely interact with study drug.

3. Known Hypersensitivity to study drug or ingredients in the study drug

4. Required use of concomitant medication known to adversely interact with study drug

5. Subjects participating in other clinical trials

6. Parents and teachers of the children not willing to sign Informed Consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy in overall growth and health of childrenTimepoint: Anthropometry Scale, <br/ ><br>Wechsler Intelligence Scale for Children (WISC, Record of schcoll attendance (Monthly), School performance & subjective parameters such as taste evaluation, Physician global evaluation for overall growth, Parents global evaluation for overall growth at Visit 1(4 weeks from baseline), Visit 2(8 weeks from baseline), Visit 3(12 weeks from baseline), Visit 4(16 weeks from baseline), Visit 5(20 weeks from baseline) and Visit 6(24 weeks from baseline)

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of Dabur Chyawanjunior in general intelligence and school performance compared with bournvita. <br/ ><br>To assess the the overall palability and likeability of Dabur Chyawanjunior and bournvita. <br/ ><br>To assess the safety of Dabur ChyawanjuniorTimepoint: 4,8,12,16,20,24 weeks from baseline