None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: Group I: 1. Healthy adult subjects of either sex aged between = 18 years. 2. Subjects willing to refrain taking any other similar medication during the study period 3. Adult subjects who have not participated in any clinical trial in the past 4 weeks. 4. Adult subjects who are willing to sign informed consent and follow the study procedure. Group II, III and IV: 1. Healthy male and female subjects aged between =13 years to =17 years in Group II, =7 years to =12 years in Group III and =3 years to =6 years in Group IV. 2. Parents/Guardians/Caregiver related to subjects, willing to give informed consent for his/her child to participate in the study. 3. Subjects aged 12-18 years of age willing to provide assent consent for his/her participation in the study along with parents/guardians/caregiver consent Subjects aged 7-12 years with oral consent along with parents/guardian/caregiver consent. Subject aged 3 to 7 years would require their parents/guardian/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 any clinical 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 neurological, cognitive, 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. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety & efficacy evaluation of HMTG-122106 gummies in healthy volunteers by subjective questionnaire and investigator assessment and monitoring of adverse events Timepoint: Safety & efficacy evaluation of HMTG-122106 gummies in healthy at the end of 7 days volunteers by subjective questionnaire and investigator assessment and monitoring of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall compliance to the study medicationTimepoint: 7 days | — |
Countries
India
Contacts
Public ContactIpsita Chowdhury
Himalaya Wellness Company
Outcome results
None listed