An Open-Label, Single-Arm, Single-Center, Phase 3 Clinical Study To Evaluate The Safety And Efficacy Of Mirror Pcos Advanced Care Tablets In Subjects With Polycystic Ovary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Metabolic-Mean change in fasting blood glucose (milligrams per deciliter) from Baseline visit to Day Thirty.
研究概览
简要总结
Summary of the Study: This Phase 3, open-label, single-arm, single-center study investigates the effect of a nutraceutical intervention in women with Polycystic Ovary Syndrome (PCOS). PCOS is a common hormonal disorder marked by ovarian dysfunction, hyperandrogenism, and polycystic ovarian morphology, often accompanied by insulin resistance, metabolic changes, and stress-axis dysregulation. Existing treatments, including lifestyle changes, oral contraceptives, insulin sensitizers, and anti-androgens, often have limited efficacy or tolerability, highlighting the need for complementary, safe interventions.
The study will evaluate the nutraceutical’s impact on metabolic health (fasting blood glucose), ovarian morphology (follicle count and ovarian volume), stress-axis function (serum cortisol), and patient-centered outcomes (quality of life and nutritional status) over 90 days.
Purpose of the Study: The study aims to assess the safety and tolerability of the nutraceutical, identify preliminary efficacy signals on metabolic, reproductive, and stress-related outcomes, and generate data for planning future randomized trials, including effect sizes, feasibility, and operational insights such as recruitment and adherence. It also seeks to provide a holistic assessment of PCOS by integrating clinical, biochemical, imaging, and patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age and Sex: Female participants aged 18–35 years at the time of informed consent.
- •Diagnosis- Clinically diagnosed with Polycystic Ovary Syndrome (PCOS) based on Rotterdam 2003 criteria.
- •General Health: Subjects with stable general health, without any acute illness or uncontrolled chronic condition that could interfere with study outcomes.
- •Contraception: If sexually active, willing to use a reliable non-hormonal contraceptive method during the study and provide a negative urine pregnancy test at Baseline.
- •Compliance: Willing and able to comply with the study requirements, including completing all scheduled visits, laboratory assessments, and questionnaires.
- •Informed Consent: Capable of understanding the study requirements and providing written informed consent prior to participation.
排除标准
- •Pregnancy and Lactation: Pregnant or breastfeeding women.
- •Recent Surgery or Trauma: History of recent major surgery, hepatic failure, or significant trauma within the last 3 months.
- •Concurrent Illness: Presence of major systemic illnesses including: o Bronchial asthma, o Hematological disorders, o Malignancies, o Cardiovascular disease, o Carcinoma, o Severe renal or hepatic dysfunction.
- •Protocol No.: CTSRS/2521 Confidential Page 16 of 35 Ver./Date: 1.0/01 Sep 2025
- •Medication Use: o Current or recent (within 3 months) use of hormonal contraceptives, anti-androgens, ovulation induction agents, or insulin-sensitizing drugs (e.g., metformin, pioglitazone).
- •o Current participation in another interventional drug study or use of investigational products within the past 3 months.
- •Allergies: Known allergy or intolerance to any of the investigational product ingredients.
- •Other Endocrine Disorders: Presence of other causes of anovulation/hyperandrogenism such as: o Non-classical congenital adrenal hyperplasia, o Cushing’s syndrome, o Hyperprolactinemia, o Androgen-secreting neoplasms, o Thyroid dysfunction.
- •Substance Use: Current smokers, alcohol or substance abuse that could interfere with adherence to study procedures.
结局指标
主要结局
Metabolic-Mean change in fasting blood glucose (milligrams per deciliter) from Baseline visit to Day Thirty.
时间窗: Screening (Day –7 to 0), | Baseline (Day 0), | Day 15 ±2 Days, | Day 30 ±2 Days (EOS)
Reproductive or Ovarian- Mean change in antral follicle count and ovarian volume (cubic centimeters) by pelvic ultrasound from Screening or Baseline to Day Thirty.
时间窗: Screening (Day –7 to 0), | Baseline (Day 0), | Day 15 ±2 Days, | Day 30 ±2 Days (EOS)
Stress Axis Biomarker- Mean change in serum cortisol (micrograms per deciliter) from Screening or Baseline to Day Thirty.
时间窗: Screening (Day –7 to 0), | Baseline (Day 0), | Day 15 ±2 Days, | Day 30 ±2 Days (EOS)
次要结局
- Nutritional and Functional Status- Change in Subject Global Assessment score from Screening or Baseline to Day Thirty.(Quality of Life- Change in World Health Organization Quality of Life BREF domain scores from Screening or Baseline to Day Thirty.)
研究者
Dr Suguru Vasudha
Sri Lakshmi Super Speciality Hospital