Effects of Shatavari (Asparagus racemosus) Root Extract Administration on Menstrual Health and Sex Hormones in Young Women: A Prospective, Randomized, Double-Blind, Two-Arm, Placebo-Controlled, 12-Week Treatment Period Study - NIL

Ixoreal Biomed Private Limited0 个研究点目标入组 160 人开始时间: 2026年7月15日最近更新: 2026年8月3日

试验速览

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•Females aged 13 to 20 years.
•Post menarche girls and young women with menarche occurring at least 12 months prior to enrolment to avoid very early physiologic irregularity.
•Body mass index 18 to 35 kilogram per meter square.
•Participants and or their legally acceptable representatives who provide written informed assent or consent to participate in the study.
•Able to read and write in English or any other vernacular language.
•No plan to commence new treatments during the study period.
•Must be willing to comply with all study procedures.

•Participants with menstrual cycle duration less than 24 days or greater than 34 days.
•Participants taking any form of herbal extract within the last 3 months before study entry.
•Participants who are on hormone replacement therapy for more than 3 months.
•Participants with any active medical, surgical, or gynaecological problems.
•Participants with a history of alcohol dependence, tobacco dependence, or any substance abuse.
•Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological, or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
•Participants with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
•Participants showing an uncooperative attitude, including poor compliance.
•Participants unable to attend follow up visits.
•Participants with any other medical condition that may, in the opinion of the Investigator, interfere with the study objective.
•Participants with known hypersensitivity to products containing Shatavari.
•Participants who have participated in other clinical trials during the previous 3 months.
•Participants with any clinical condition which, according to the Investigator, does not allow safe fulfilment of the clinical trial protocol.

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