CTRI/2025/10/096231招募中不适用
A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).
MotherSoul Private Limited3 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年11月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Mean change in Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) ratio from baseline to end of study.
研究概览
简要总结
“A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).”
Primary Objective:
To evaluate the efficacy of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).
Secondary Objective:
To evaluate the safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult female participants, 18 to 40 years of age (both inclusive) both married or unmarried.
- •Participants with USG confirmed diagnosis of polycystic ovarian disease.
- •Participants with LH/FSH ratio greater than or equal to 2:
- •Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation.
- •Participants with uterine fibroid, polyp, adenomyosis, ovarian mass or tumour.
- •Participants with a known history of tubercular endometriosis.
- •Participants with known history of congenital adrenal hyperplasia, congenital absence or deformities of uterus and ovaries.
- •Participants having congenital anomalies in the female genital tract.
- •Participants with a current use of hormonal contraceptives or any drugs that may have an influence on the outcome of the study.
- •Participants who have been using fertility drugs within 6 months of the study.
- •Participants diagnosed with premature ovarian failure and dysfunctional uterine bleed.
- •Participants with a history of malignancy or any ongoing malignancy.
- •Participants with known history of uncontrolled hypertension or uncontrolled Type 2 Diabetes Mellitus.
- •Participants with any thyroid abnormalities or dysfunctions at screening.
- •Participants with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts); or cerebrovascular accident.
- •Participants with clinically relevant current or past history of severe, unstable, or uncontrolled pulmonary, hepatic, endocrine, neurological, rheumatological and renal diseases necessitating medical care.
- •Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant.
- •Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Participants who are pregnant or lactating or planning to become pregnant during the study period.
结局指标
主要结局
Mean change in Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) ratio from baseline to end of study.
时间窗: 90 Days
次要结局
- Change in ovarian volume and appearance assessed with pelvic (abdominal) sonography from baseline to end of study.(90 Days)
- Mean change in total testosterone from baseline to end of study.(90 Days)
- Mean change in severity of pain during menstruation assessed using Visual Analog Scale from baseline to end of study.(90 Days)
- Mean change in bleeding using the Menstruation Assessment Chart from baseline to end of study.(90 Days)
- Mean change in menstrual cycle intervals (in days) assessed with last menstrual period (LMP) from baseline to end of study.(90 Days)
- Mean change in mood swings using the Hospital Anxiety and Depression Scale (HADS) assessment from baseline to end of study.(90 Days)
- Mean change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) assessment from baseline to end of study.(90 Days)
- Mean change in hirsutism using the modified Ferriman – Gallwey Score assessment from baseline to end of study.(90 Days)
- Mean change in BMI and waist circumference from baseline to end of study.(90 Dyas)
- Safety Endpoint:(The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters.)
研究者
Dr Alaka C Godbole
Akshaya Surgical and Maternity Home
研究点 (3)
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