A randomized double-blind placebo-controlled multicentric clinical study to evaluate the safety and efficacy of Shatavari (asparagus racemosus) in improving hormonal health in healthy reproductive women.

Aurea Biolabs (P) Limited2 个研究点分布在 1 个国家目标入组 66 人开始时间: 2025年9月1日最近更新: 2026年3月25日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方
入组人数: 66
试验地点: 2
主要终点: Blood Hormone Tests – will be done in the range as per the table in inclusion criteria on the 2nd day of all the cycles (4 cycles) - Total of 4 points

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

The study population consists of healthy premenopausal women aged 30 - 42 years who are experiencing symptoms of hormonal imbalance, such as irregular menstrual cycles, mood swings, anxiety, and loss of libido. These participants are selected based on their eligibility criteria, ensuring a homogenous group suitable for evaluating the investigational product’s efficacy and safety. Participants must exhibit borderline hormonal levels based on the inclusion criteria, measured on Day 2 ± 1 of the menstrual cycle (early follicular phase). Hence, 60 subjects must be enrolled and receive either a test product or Placebo in this study at the investigative site as per the nature of the population mentioned above.

研究设计

研究类型: Interventional
分配方式: Other
盲法: Double

入排标准

年龄范围: 30.00 Year(s) 至 42.00 Year(s)（—）
性别: Female

入选标准

•Fertile women between
•42 years of age (in reproductive age) Normal BMI, not obese or underweight (BMI range 18.5 to 29.9) Experiencing symptoms associated with hormonal imbalance like: MEDI-Q: Moderate symptoms Borderline Hormone levels in accordance with the table below (as per Gynecologists): Hormone Inclusion Range Units Estradiol (E2): 30-70 pg/mL Progesterone: 0.2-0.6 ng/mL FSH: 3.5-5.5 IU/ml LH: 8-15 IU/ml Testosterone: 35–48 ng/dL DHEA: 150-300 mcg/dL AMH: 3-5 ng/mL All these tests will be done on Day 2 ± 1 of the Menstrual Cycle Phase i.e., early follicular phase.

排除标准

•Unwillingness to sign the Inform Consent Form.
•Females with PCOS, primary ovarian failure, thyroid dysfunction, hyperprolactinemia, systemic illnesses, malignancy.
•Pregnant and lactating females Secondary dysmenorrhea diagnosed (fibroids, endometriosis, or cysts), presence of a history of abortion Use of antidepressants and/or psychotropic medication in the last two months Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
•Subject has a history of alcohol or other drug abuse in the past year.

结局指标

主要结局

Blood Hormone Tests – will be done in the range as per the table in inclusion criteria on the 2nd day of all the cycles (4 cycles) - Total of 4 points