A prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of VITEX extract in subjects suffering with Post Menopausal Syndrome.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Endpoints:
研究概览
简要总结
Postmenopausal Syndrome (PMS) refers to a collection of symptoms occurring after the cessation of menstruation, affecting women’s physical, emotional, and mental well-being. With aging populations globally, effective management of PMS has become a public health priority.Menopause symptoms severely reduce the quality of life of women worldwide, with up to 80% of women experiencing symptoms. It is estimated that by 2030, the groups of post-menopausal women will reach 1.2 billion globally (Gold et al. 2006). During menopause, women undergo biological, social, and psychological changes and are sensitive to stressors, especially anxiety and depression. Decreased estrogen in postmenopausal women causes mood swings, especially depression and anxiety. Menopausal symptoms have remarkable negative effects on women’s quality of life, justifying the need to assess various therapeutic options.
Vitex is a genus belonging to the sage family, Lamiaceae, and comprises around 250 species. Commonly referred to as the chaste tree or chastetree, the term often specifically denotes Agnus castus but is also applied to other species. Native to regions of middle Asia and the Mediterranean, Vitex has a long history of use in treating various menstrual issues. Historically, it was believed to reduce sexual desire, which is why it is called the "chaste tree," with “agnus” meaning "chaste" in Greek and “castus” carrying the same meaning in Latin. The chaste tree (Vitex agnus-castus) contains a diverse range of chemical components, including Flavonoids, Glycosides, Organic acids, Alkaloids, Essential oils, Diterpenoids and Sterols. Although its active ingredient has not been identified, the herb’s bioactive constituents, particularly flavonoids and diterpenes, contribute to its therapeutic properties. Derived from the fruit of Vitex agnus castus (Chasteberry). Extracts of chaste tree are prepared from the leaves, tender stems, flowers, and seeds and provided as syrup, elixir, powder, or a component of a multi ingredient dietary supplement. Also available in various forms: capsules, tablets, supplements. Traditionally used for hormonal balance, menstrual issues, and menopausal symptoms May help with PMS symptoms, Menstrual irregularities, Fertility issues and Menopausal symptoms (hot flashes, mood swings).
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
- 40.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Menopausal transition (if menstruation has not occurred for more than 3 months).
- •2.Those with FSH (Follicle stimulating hormone) exceeding 30 mIU/mL.
- •3.Women aged 40 to 65 who are in menopause (more than 1 year after the last menstruation).
- •4.Those with a KI (Kupperman Index) score of 25 or higher.
- •5.Those who complain of clinical menopausal symptoms even if their KI score is less than 25.
排除标准
- •Drug use 1.Women who have used hormone preparations such as female hormones or similar hormone preparations plant extracts etc within the past 3 months 2 Drug addicts 3 Those who have used thyroid hormone preparations Clonidine anticoagulants or antithrombotic drug Aspirin Warfarin Clopidogrel etc within the past 3 months 4 Those who have taken medicines related to female menopause or health functional foods within the past 1 month 5 Those who are taking or administering osteoporosis treatment drugs such as bisphosphonates Disease status 6 Those with a body mass index(BMI exceeding 30 kg per m 2 7 Those with a history of endometrial hyperplasia uterine cancer endometrial cancer cervical cancer breast cancer breast disease or cancer related to sex hormones 8 Those who have undergone hysterectomy 9 Women who have had severe migraines thromboembolism cerebrovascular disease myocardial infarction unstable angina within the past year or have had coronary angioplasty 10 Women with mental illnesses such as depression or anxiety disorder or who are currently taking antidepressants or other psychotropic drugs 11 Women with undiagnosed abnormal uterine bleeding 1 year after menopause 12 Those with uncontrolled hypertension SBP 140 mmHg or DBP 90 mmHg 13.Those with uncontrolled diabetes HbA1C 7 0 14 Those with thyroid-stimulating hormone TSH levels above those outside the normal range 15 Those with ALT and AST levels 3 times higher than the upper limit of normal 16 Those with eGFR less than 60 mL min1.73m 2 17 Those with endometrial thickness 7 mm.
结局指标
主要结局
Primary Endpoints:
时间窗: Day 0, Day 30 and Day 60
1.Changes in MENQOL
时间窗: Day 0, Day 30 and Day 60
2.Changes in MRS score
时间窗: Day 0, Day 30 and Day 60
3.Changes in QOL questionnaire
时间窗: Day 0, Day 30 and Day 60
次要结局
- Secondary Endpoints(1.Changes in Reduction in hot flushes & Night sweats)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt Ltd.
