None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adult females within age group of 18 to 40 years. 2.Healthy females as determined by the investigator based on a medical evaluation including medical history, physical examinations, and laboratory examinations. 3.Subjects willing to sign an informed consent document. 4.Subjects willing to adhere to protocol requirements throughout the study period. 5.Subjects who have not participated in any clinical study in the past 30 days
Exclusion criteria
Exclusion criteria: 1.Subjects with known clinically significant serious cardiovascular, neurological, respiratory, gastrointestinal, genitourinary, congenital or any other disorder as determined by the investigator. 2.Women who are pregnant, nursing, or planning a pregnancy during study entry and throughout the duration of the study. 3.Subjects with lactose intolerance (as the IP is to be taken with milk). 4.Subjects with known allergies to any of the ingredients of the investigational product. 5.Subjects with clinically significant pre-existing systemic disease necessitating long-term medications as determined by the investigator. 6.Subjects not willing to refrain from using adequate contraception and hormonal medications one month prior and during the study. 7.Subjects not willing to refrain from taking any other similar supplements during the study period. 8.Subjects not willing to abstain from excessive intake of recreational products like tobacco/pan chewing, smoking, alcohol and any other as determined by the investigator during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Galactagogue in healthy adult females by the following assessments: 1.General Physical Examinations 2.Laboratory Examinations 3.Adverse events Timepoint: Day 1 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE): AEs/SAEs will be continuously monitored throughout the duration of the study Timepoint: 7 Days | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed