None listed
Conditions
Interventions
Intervention1: Pedia Power: Route of Administration : Oral
Formulation : Powdered Nutritional Formulation
Dose : 50g (5 scoops) in 150ml luke warm water
Dosage : OD for 3 months
Control Intervention1
Sponsors
Essen Fooddies India Pvt Ltd
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically healthy children between aged 5 and 14 years (both ages and all genders inclusive). 2. Children must be able to comprehend the language spoken and must have mastered verbal communication enough to understand and answer questions. 3. Children whose parents/guardian are willing to sign the informed consent for participation in the clinical study and are able to understand and ensure that their child/ward follows the responsibilities of the study. 4. Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health. 5. Subjects who have scored =1 in STRONGKids Questionnaire at the time of screening. 6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to the ingredients of the investigational product. 2. Children who are identified with Galactosemia, Type I Diabetes Mellitus, Epilepsy and any other disorder that limits normal nutritional intake 3. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study. 4. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 5. Subjects on remission from cancer of any type less than 5 years at the time of screening 6. Subjects who have participated in a clinical study less than 1 month before screening 7. Any significant medical condition (e.g., significant psychiatric or neurological disorders), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 8. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 9. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Anthropometric Measurements: Improvement of 10% from baseline. 2.Fluency Test: Improvement of 10% from baseline. 3.General Appetite: Improvement of 10% from baseline. 4.IPFBQ: Total Score of 20. Timepoint: 1. Anthropometric Measurements : Day 1, Day 45, Day 90 2. Fluency Test : Day 1, Day 45 Day 90 3. General Appetite : Day 1, Day 45, Day 90 4. IP Feedback Questionnaire : Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed