A randomized, placebo-controlled, parallel arm clinical study to evaluate the efficacy and safety of Female Health Support (GP/PROD/2025/005) in perimenopause symptoms in women.

Gplife Healthcare Pvt Ltd1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新: 2025年3月6日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: Assessment of-

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized, placebo-controlled clinical study aims to evaluate the efficacy and safety of Female Care supplementation (GP/PROD/2025/005) in managing perimenopause symptoms. The study will enroll 60 women, equally divided between test and placebo groups, over three menstrual cycles. Participants will undergo four scheduled visits, from screening through three menstrual cycles. The study will assess multiple endpoints including changes in menopausal symptoms using the Blatt and Kupperman Index, sleep quality, hormone levels (estradiol, FSH, DHEAS), depression scores, fatigue severity, mood status, and quality of life. Safety monitoring includes blood parameters, vital signs, and adverse events tracking. The comprehensive evaluation will measure both physiological and psychological aspects of perimenopause, along with product compliance and tolerability.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 40.00 Year(s) 至 55.00 Year(s)（—）
性别: Female

入选标准

•Participants meeting all the following criteria will be eligible for the study:
•Female participants of age between 40-55 years (both inclusive);
•Must be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue, lack of energy, hot flashes, night sweats, irritability, anxiety.
•Beck Depression Inventory 2nd Edition score not more than 19 (minimal-mild depression) at screening;
•Participants in good general health, in the opinion of the investigator, based on medical history, physical examination and clinical examination at screening.
•Female participants willing to provide informed consent.

排除标准

•Participants meeting any of the following criteria will not be eligible for the study: 1.Current or previous history of any malignancy; 2.Women undergoing hormone replacement therapy; 3.Any clinically significant prior or ongoing history of gynecological disorders, kidney/liver disease, thyroid disorder; 4.Any other history, condition, therapy, or uncontrolled intercurrent illness which could, in the opinion of the investigator, affect compliance with study requirements; 5.History of food or pollen allergy; 6.Clinically relevant drug or alcohol abuse or smoking; 7.Pregnant or nursing; 8.Participant using or had used any herbs, dietary supplements, medicines or hormonal therapy that contained estrogenic compounds; 9.Participation in any other clinical study within the past 3 months or ongoing; 10.Significant mental health issues that could affect study findings, such as anxiety, depression, or other mental health disorders; 11.Any other reason that, in the opinion of the investigator, excludes the subject from eligibility for study participation; 12.Inability to provide reliable data due to Cognitive impairment or language barriers that may prevent accurate reporting of symptoms.