An Open-Label, Single Arm Clinical Study to Evaluate the Safety of HGLG-032406 (IN-100001206) in Healthy Adult Females.
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Completed
- Sponsor
- Himalaya Wellness Company
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- To evaluate the safety of Galactagogue in healthy adult females by the following assessments:
Study Overview
Brief Summary
**Title:**An Open-Label, Single Arm Clinical Study to Evaluate the Safety of HGLG-032406 (IN-100001206) in Healthy Adult Females.
Protocol Number: HWC/MSCD/PP/006/2024 Version: 1.0, Dated 25th Mar 2024
Study Type: Interventional
Duration: 7 days
Number of Subjects: 12 evaluable subjects
Study Arms: Single Arm Study
Visits: 3 visits (Visit1: Screening, Visit 2:Baseline, Visit 3:End of study)
Study Population: Healthy adult females aged 18 to 40 Study
Design: Open-Label, Single Arm Clinical Study
This single-arm clinical study aims to assess the safety of HGLG-032406 in healthy adult females over a 7-day period. The study will involve 12 evaluable subjects aged 18 to 40. Eligible subjects will receive the investigational product on Day 1 and will be monitored through three visits for general physical examinations, laboratory tests, adverse events, and feedback on product experience. Inclusion criteria emphasize overall health and willingness to adhere to the study protocol, while exclusion criteria include significant medical conditions, pregnancy, allergies, and unwillingness to refrain from certain substances during the study period. The dosage will be 10 grams twice daily with milk for 7 days.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
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
- •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.
Outcomes
Primary Outcomes
To evaluate the safety of Galactagogue in healthy adult females by the following assessments:
Time Frame: Day 1 and Day 7
1. General Physical Examinations
Time Frame: Day 1 and Day 7
2. Laboratory Examinations
Time Frame: Day 1 and Day 7
3. Adverse events
Time Frame: Day 1 and Day 7
Secondary Outcomes
- Adverse events (AE): AEs/SAEs will be continuously monitored throughout the duration of the study(7 Days)
Investigators
Dr Radhika S Kamuni
Xplora Clinical Research Services Pvt Ltd