An Open-label, Single-center, Randomized, Exploratory, Dose-finding Study to Evaluate Short Term Treatment With Different Doses of Oral Powdered Kudzu Root Extract in Women With at Least Mild Menopause Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Menopause Rating Scale (MRS)
研究概览
简要总结
The aim of the study is to investigate effects of daily intake of Nordic Kudzu for 28 days in 5 groups of 10 menopausal women with symptoms. Groups:1) 3 capsules x3/day, 2) 3 capsules x2/day, 3) 2 capsules x3/day, 4) 2 capsules x2/day, 5) 3 capsules x1/day. Each capsule equal 1.26 g kudzu root extract. Outcome measures: Serum and urine levels of biochemical marker of bone-degradation, CTX-I, and symptoms of menopause using the Meopause Rating Scale (MRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Women in the age between 45 and 60 years considered late peri- (defined as having had a menstrual period more than 3 months ago but less than 12 months ago) or postmenopausal (defined as at least 12 consecutive months without any menstrual flow) at the time of screening
- •Menopause symptoms, defined as a score of at least 5 in the Menopausal Rating Scale (MRS) at screening
- •Body Mass Index between 18 and 40 kg/m2 at the time of screening
排除标准
- •Allergy/hypersensitivity/intolerance to any components in the Kudzu herbal extract powder capsules
- •Past or present significant co-morbidity including, but not limited to: Uncontrolled, severe renal, hepatic, cardiovascular, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease
- •History of breast cancer or other malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
- •Known history of clinically significant thromboembolism
- •Current alcohol abuse
- •Pregnancy, determined by positive serum human chorionic gonadotropin (hCG) test prior to randomization, except for women considered postmenopausal
- •Breastfeeding women
- •Participation in a study trial with any investigational new drug or food supplement within 3 months prior to the start of the study
- •Clinically significant ECG abnormalities, as judged by the investigator
- •Clinically significant biochemistry abnormalities including but not limited to ALT or AST >2.5 x ULN or other clinically significant liver function parameters, as judged by the investigator
- •Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination
- •Use of local or systemic conventional hormone therapy regardless of indication or alternative medication including dietary supplements for the treatment of menopausal symptoms within 28 days prior to randomization.
研究组 & 干预措施
Group 1
10 subjects
干预措施: 3 caps x3/day (Dietary Supplement)
Group 2
10 subjects
干预措施: 3 caps x2/day (Dietary Supplement)
Group 3
10 subjects
干预措施: 2 caps x3/day (Dietary Supplement)
Group 4
10 subjects
干预措施: 2 caps x2/day (Dietary Supplement)
Group 5
10 subjects
干预措施: 3 caps x1/day (Dietary Supplement)
结局指标
主要结局
Menopause Rating Scale (MRS)
时间窗: 28 days
Questionaire. 11 likert scales 0-4. Total score ranges: 0-44 (0 indicating no symptoms, 44 indicating max symptoms.
Serum CTX-I
时间窗: 28 days
Blood based biomarker of bone resorption
Urine CTX-I
时间窗: 28 days
Urine based biomarker of bone resorption
次要结局
未报告次要终点