None listed
Conditions
Interventions
None listed
Sponsors
DABUR INDIA LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Male & female children between 5-12 years of age (both inclusive). 2. Medically stable with no requirement of drugs, or any interventions/procedures or any nutraceutical / health supplement. 3. Children who are willing to drink milk regularly. 4. Parents/ Legally Acceptable Representative of children willing to provide an informed consent. 5. No significant medical or surgical disease/s at the time of screening 6. No history of allergic response to Chyawanprash like products/any ingredients of the Chyawanprash and are not averse to taste of Chyawanprash 7. Willing to come for the follow up visits for evaluation
Exclusion criteria
Exclusion criteria: 1. Children with any underlying physical, psychological or surgical condition. 2. Children who are reluctant to drink milk regularly. 3. Children who required use of concomitant medications 4. Children who are currently taking any health supplement/nutraceuticals. 5. Known hypersensitivity to study drug or ingredients in the study drug. 6. Subjects participating in other clinical trials 3 months before recruitment. 7. Parents and teachers of the children not willing to sign Informed Consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Immunity, cognitive health and quality of lifeTimepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety assessment basis incidence of adverse events, serious adverse events, and vitals during the study period. 2. Overall safety and tolerability of product by the physician and participant/parent will be evaluated at the end of the study. Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Lokeshwari H S
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center
Outcome results
None listed