None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: Each subject must meet all the following criteria to be enrolled in this study: 1) Adult volunteers of either sex with good health. 2) Aged between �18 to � 60 years. 3) Subjects willing to sign informed consent and follow the study procedure and instructions. 4) Has not participated in a similar investigation in the past four weeks. 5) Women in reproductive age group who will agree to follow an acceptable contraceptive method.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1) Subjects with clinically significant cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other systemic condition requiring therapeutic intervention. 2) A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the test products. 3) Pre-existing systemic disease necessitating long-term medications. 4) Genetic and endocrinal disorders. 5) Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the safety of HTUL-031908 with number of adverse events observed or reported during the study period in healthy adult volunteers 2. To assess the tolerability and sensory evaluation of HTUL-031908 with total compliance to the study intervention Timepoint: ââ?¬Â¢Visit 1 Screening/-1 week ââ?¬Â¢Visit 2 Day1/ screening ââ?¬Â¢Visit 3 Day 8/ End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed