CTRI/2025/11/096876招募中不适用
A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women.
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
- Proportion in Menopause Rating Scale (MRS) assessment 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 Capsules for the treatment of Menopausal Symptoms in women.
Primary Objective:
To evaluate the efficacy of Shatavari Capsules for the treatment of Menopausal Symptoms in women.
Secondary Objective:
To evaluate the safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult menopausal female participants, 40 to 70 years of age (both inclusive).
- •Perimenopausal and postmenopausal participants who are experiencing bothersome Vasomotor Symptoms.
- •Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months; post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months.
- •Participants with menopause symptoms, defined as a score of greater than or equal to 9 to less than or equal to 16 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women).
- •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 present active medical, surgical, and gynaecological problems.
- •History of malignancy or any ongoing malignancy.
- •Participants with known history of uncontrolled hypertension and uncontrolled Type 2 Diabetes Mellitus.
- •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.
- •Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- •Participants taking medications such as glucocorticoids, anticonvulsants, antipsychotics, anxiolytics, antidepressants, opioid pain relievers, hypnotics, methotrexate, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •Participants with sleep disturbances and who are on prescription/over the counter/herbal/nutraceutical or any other system of therapy for sleep related concerns.
- •Participants using phytoherbal supplements, herbal extracts, nutraceuticals, or ayurvedic supplements 3 months prior to screening.
- •Participants who are consuming or planning to consume soy/estrogenic foods like soybean oil or other estrogenic diet supplements.
- •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
Proportion in Menopause Rating Scale (MRS) assessment from baseline to end of study.
时间窗: 60 Days
次要结局
- Mean change in Menopause Rating Scale (MRS) assessment from baseline to end of study.(60 Days)
- Mean change in Utian Quality of life Scale (UQOL) assessment from baseline to end of study.(60 Days)
- Mean change in Depression Anxiety Stress Scale (DASS-21) assessment from baseline(to end of study.)
- Mean change in Greene Climacteric Scale assessment from baseline to end of study.(60 Days)
- 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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