A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Overall Menopausal Symptoms
研究概览
简要总结
This 12-week study is a randomized, placebo-controlled study assessing the efficacy of an herbal blend on menopausal symptoms and quality of life.
详细描述
The purpose of this study is to evaluate changes in menopause symptoms after taking an herbal supplement daily for 12 weeks compared to placebo (a tablet that does not have active ingredients). This is a remote study, meaning all study data will be collected via the ClaimIt app, with the exception of a screening lab appointment and a Week 12 lab appointment.Participants will be asked to report on study compliance and respond to a series of questionnaires relating to symptoms of menopause, hot flashes, and quality of life.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
A unique ID number will be assigned by ClaimIt to each enrolled subject and associated with the correct study product kit number; this number will be used throughout the study. Both the study product and placebo will be labeled identically except for kit number and will be distinguishable only by the individual participant ID and kit number.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females between 40 and 65 years of age
- •Report experiencing moderate to severe menopausal symptoms, characterized as including all of the following:
- •Total Score of 11 or greater on the Greene Climacteric Scale (GCS) Questionnaire
- •Self-reported frequent hot flashes experienced (estimated minimum of 28 during the past week, or an average of a minimum of 4 in a typical day)
- •Absence of a regular menstrual cycle, defined as either: an irregular cycle for at least 6 months, or the absence of menses for 3 or more months
- •Agreement to maintain current level of physical activity throughout the study period
- •Willingness and ability to follow the procedures of the study
- •Willingness and ability to provide informed consent
排除标准
- •Participant with a Body Mass Index (BMI) ≥ 30mg/kg2
- •Participant who has had both ovaries removed
- •Women who are pregnant, breastfeeding, or planning on becoming pregnant during the course of the study
- •A history of breast cancer or a positive mammogram
- •A history of uterine cancer or an abnormal pap smear
- •Abnormal vaginal bleeding (not related to menstrual irregularity)
- •Liver disease
- •A history of clinically diagnosed depression that a medical professional recommended should be medically treated
- •A history of clinically diagnosed hypertension (systolic of 140 mmHg or greater or diastolic of 90 mmHg or greater)
- •Hyperthyroidism determined by thyroid stimulating hormone (TSH) screening
- •Any unstable medical condition as determined by the Principal Investigator (PI)
- •Any significant clinical or laboratory abnormality identified by the PI
- •Any change in the use of dietary supplements in the 2-month prior to enrollment
- •The use of any product indicated for menopause symptoms in the 2 months prior to enrollment including: prescription drugs (e.g. estrogen/progestins), over-the-counter supplements (e.g. black cohosh, soy isoflavones, evening primrose oil, phytoestrogens, etc), or a significant change in diet to include more soy foods.
- •The use of any psychiatric drugs in the 6 months prior to enrolling
- •Self-reported abuse of drugs or alcohol
- •Any smoking of cigarettes, vaping or e-cigarettes, or consumption of other tobacco products within the past 6 months
- •Planned donation of blood during or up to 30 days after completion of the study
- •An allergy to any ingredient in the herbal blend product or placebo
- •A sensitivity to botanical extracts
- •Previous participation in a clinical research study less than 30 days prior to randomization to a treatment group
- •Any other condition that in the investigator's opinion may adversely affect the participant's ability to complete the study, or may pose a significant risk to the participant
结局指标
主要结局
Overall Menopausal Symptoms
时间窗: 12 weeks
Change from baseline in global menopausal symptoms assessed by the Greene Climacteric Questionnaire at Week 12. The Greene Climacteric Questionnaire is a 21-item validated questionnaire that provides a measurement of global menopause symptoms, grouping questions into psychological, physical, vasomotor, and sexual domains. Participants answer on a 4-point scale. Each response is given a numerical value from 0 to 3 points respectively, and the sum total of their 21-point responses is calculated as their GCS score.
次要结局
- Overall Menopausal Symptoms(8 weeks)
- Incidence/severity of hot flash episodes(12 weeks)
- Feelings of fatigue(12 weeks)
- Vaginal dryness(12 weeks)
- Health-related quality of life (EQ-VAS)(12 weeks)
- Perception of wellness(12 weeks)