A Randomized, Double Blind, Placebo Controlled, Parallel Study to Evaluate the Efficacy and Safety of Shatavari (Asparagus racemosus) On Healthy Subjects with Postmenopausal Syndrome for 12 Weeks.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Outcome:
研究概览
简要总结
Menopause is one of the most significant events in a woman’s life and brings in a number of physiological changes that affect the life of a woman permanently. There have been a lot of speculations about the symptoms that appear before, during and after the onset of menopause.Menopausal transition, or ‘perimenopause’, is a defined period of time beginning with the onset of irregular menstrual cycles until the last menstrual period, and is marked by fluctuations in reproductive hormones [6]. This period is characterized by menstrual irregularities; prolonged and heavy menstruation intermixed with episodes of amenorrhea, decreased fertility, vasomotor symptoms; and insomnia. Some of these symptoms may emerge 4 years before menses cease [7]. During the menopausal transition, estrogen levels decline and levels of FSH and LH increase. The menopausal transition is characterized by variable cycle lengths and missed menses, whereas the postmenopausal period is marked by amenorrhea. The menopausal transition begins with variability in menstrual cycle length accompanied by rising FSH levels and ends with the final menstrual period.
Shatavari is rich in a diverse spectrum of bioactive compounds, including flavonoids, phenolic substances, tannins, alkaloids, terpenes, steroids, and notably, saponins. A range of unique phytochemicals—such as racemoside A, B, and C, immunoside, filiasparoside C, asparinins, asparosides, curillins, and curillosides—have been identified in its extracts. Among these, the Shatavarins, a group of steroidal saponins unique to Shatavari, stand out due to their significant therapeutic potential. These compounds have been shown to exhibit a variety of beneficial effects, including immune modulation, support for female reproductive health, anti-stress and anxiolytic activity, lactogenic effects, and even anti-cancer properties
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female age 45-65 with Kupperman Index score greater than or equal to 25
- •Those who meet one of the following menopause criteria a.
- •Women with spontaneous amenorrhoea for 12 months after the last menstrual period b.
- •Women with spontaneous amenorrhoea for 6 months with a blood FSH level greater than 30 mIU/mL.
- •Those who voluntarily agrees to participate and signs in informed consent form.
排除标准
- •Those with a history of hypersensitivity to drugs or food ingredients.
- •Those who have been taking menopausal related medicines health functional food extracts of Salvia miltiorrhiza Rhapontic rhubarb root fermented germinated soybean complex of soybean and hop Lactobacillus acidophilus YT1 Schisandra chinensis pomegranate complex of Cyanchum wilfordii red ginseng pycnogenol French maritime pine bark etc.
- •or herbal medicine continuously within one month prior to screening.
- •Those who have been taking hormone preparations such as female hormones or similar hormone preparations Western horseback riding St. John’s Wort red clover Agnus castus fruit etc.
- •within 3 months prior to Screening.
- •Those who have been taking estrogen related drugs within 6 months prior to screening.
- •Those undergoing hormone replacement therapy HRT treatment to relieve menopausal symptoms 1 month prior to screening.
- •Those who are taking osteoporosis treatment selective estrogen receptor Modulator bisphosphonate etc.
- •Those who have been using vaginal moisturiser to relief from vaginal dryness.
- •Those with irregular uterine bleeding after 1 year of menopause.
- •Those with clinically significant abnormality confirmed by mammography Breast Imaging Reporting and data system Category 0 or 3 or higher.
- •However in case of BI RADS category 0 registration is possible at the discretion of the examiner.
- •Those with endometrial hyperplasia uterine cancer endometrial cancer breast cancer breast disease symptoms or sex hormone related diseases.
- •Those who have had hysterectomy.
- •Those with endometrial thickness greater than 7 mm by vaginal sonogram.
- •Those with body mass index BMI lower than 18 kg per m2 or greater than 30 kg per m
- •Those with severe cerebrovascular disease cerebral infarction cerebral hemorrhage etc.
- •heart disease angina pectoris myocardial infarction heart failure arrhythmia in need of treatment lung disease chronic obstructive pulmonary disease etc.
- •within the last 6 months However those who are clinically stable may participate in the trial at the investigator’s discretion.
- •Participants who have irregular dietary habit and intakes excessive Alcohol caffeine and smoke.
- •Those with a serious dysfunction of the liver alanine and aspartate aminotransferase levels of 3 times the upper limit of normal or kidney creatinine greater than 2.0 mg/dL.
- •Those with hypertension blood pressure greater than or equal to 160/100 mmHg.
- •Those with thyroid disease or TSH level is abnormal or out of the normal range specified by the site
- •Those who have having thyroid related hormone drugs, clonidine anticoagulant or antithrombotic drugs aspirin warfarin clopidogrel etc.
- •Those with malignant tumour diagnosed within 3 years prior to screening.
- •Those with a psychologically significant medical history, currently taking psychiatric drugs of antidepressant sleeping pills SSRI Gabapentin Benzodiazepine etc.
- •or current disease schizophrenia Epilepsy anorexia bulimia etc.
- •or a history of alcohol or the other drug abuse.
- •Participants who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period.
- •Those who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion.
结局指标
主要结局
Primary Outcome:
时间窗: Screening Visit, Day 42, Day 84
Modified Kupperman Index Total Score
时间窗: Screening Visit, Day 42, Day 84
次要结局
- Secondary outcomes:(• Menopause-Specific Quality of Life Total Score)
- Secondary Outcomes:(• Osteocalcin)
研究者
Dr Ashok Godavarthi
Radiant Research Services Private Limited