None listed
Conditions
Interventions
Intervention1: Herbal formulation: 10 ml of formulation twice a day for 30 days
Control Intervention1: Nil: Nil
Sponsors
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy children of either sex of 3-13 years (both inclusive) Ready to provide informed consent from parent/ legally accepted Guardian No significant medical or surgical disease/s at the time of screening No history of allergic conditions at screening by the related ingredients like investigational product Willing to come for the follow up visits for evaluation
Exclusion criteria
Exclusion criteria: Presence of any clinically significant medical or surgical condition requiring long term treatment Subjects participating/participated in another clinical study within 3 months before recruitment Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation Immunologically compromised children
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of episodes, severity and duration of illness during the study period Complete Hemogram Serum IgG, IgM Levels of CD3,4 and 8 cells Timepoint: On screening day 15 and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Digestive behavior questionnaire analysis Assessment of energy and stamina in parent reported questionnaire Drug compliance Tolerability of study drugs Adverse events/ Adverse drug reactions Timepoint: On screening day 15 and day 30 | — |
Countries
India
Contacts
Public ContactMr Sharad Dhurde
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Outcome results
None listed