None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: Adult population: 1.Healthy adult subjects of either sex aged between � 18 to � 50 years. 2.Subjects willing to refrain taking any other similar medication during the study period 3.Adult subjects who have not participated in this kind of trial in the past 4 weeks 4.Adult subjects willing to sign informed consent and follow the study procedure. Pediatric Population: 1.Healthy male and female pediatric subjects aged between �2 years to �12 years. 2.Parents/Guardians/Caregiver related to pediatric subjects 3.Pediatric subjects aged > 7 years of age willing to provide oral consent for his/her participation in the study along with parents/guardians/caregiver consent (Refer protocol section 11.4, Informed Consent Process) 4.Pediatric Subjects willing to refrain taking any other similar medication during the study period 5.Pediatric subjects who have not participated in this kind of trial in the past 4 weeks. 6.Parents/ Guardians/ Caregivers of the pediatric subjects willing to sign informed consent/assent (as applicable) and follow the study procedure.
Exclusion criteria
Exclusion criteria: 1.Subjects with clinically significant serious cardiovascular, respiratory,cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder. 2.A known history or present condition of allergic response to the study products its components or ingredients in the investigational product. 3.Pre-existing systemic disease necessitating long-term medications. 4.Subjects who refused to sign informed consent. 5.Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any adverse or serious adverse events during the study period.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall compliance to the study medicationTimepoint: 7 days | — |
Countries
India
Contacts
Public ContactKavitha Rangaiah
Himalaya Wellness Company
Outcome results
None listed