None listed
Conditions
Interventions
Intervention1: Chyawan Junior: Health supplement in the form granules having chocolate colour. 2 tea spoonful with glass of milk, twice daily for 6 months
Control Intervention1: Bournvita: Health supp
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy in overall growth and health of childrenTimepoint: Anthropometry Scale, 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
| Measure | Time frame |
|---|---|
| To assess the efficacy of Dabur Chyawanjunior in general intelligence and school performance compared with bournvita. To assess the the overall palability and likeability of Dabur Chyawanjunior and bournvita. To assess the safety of Dabur ChyawanjuniorTimepoint: 4,8,12,16,20,24 weeks from baseline | — |
Countries
India
Contacts
Public ContactDr Arun Gupta
Dabur India Limited
Outcome results
None listed