CTRI/2024/04/066274
Not yet recruiting
Phase 1
An Open-Label, Single Arm Clinical Study to Evaluate the Safety of HGLG-032406 (IN-100001206) in Healthy Adult Females. - Nil
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Himalaya Wellness Company
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Not specified
Similar Trials
Not yet recruiting
Phase 1
A study on HSLG-032303 capsules in treating Low Libido in adult males.CTRI/2024/05/067134Himalaya Wellness Company
Completed
Not Applicable
Clinical Study to check the Safety and Effectiveness of Test Baby Diaper in 0 to 36 Months of Age Healthy Babies and Babies with irritated, red, dry, bumpy, itchy skiCTRI/2021/10/037375R for Rabbit Baby Products Pvt Ltd32
Completed
Not Applicable
A clinical study to evaluate the effect of a Diaper Rash Cream in Healthy Babies of 6 to 36 Months of Age.CTRI/2024/05/066744prising Science Private Limited36
Recruiting
Phase 4
To study effect of combination of varico-repair capsule and oil on varicose veinsCTRI/2022/11/047743Mittal Ayurved Sansthan
Recruiting
Phase 4
To check efficacy of wundschutzgel in sunburHealth Condition 1: T231- Burn of first degree of wrist andhandCTRI/2022/09/045569TRIN GmbH