An 8-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Herbal Extract With Natural Bio-Enhancer Additives on Menopausal Symptoms in Post-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Menopause Rating Scale (MRS) Total Score
研究概览
简要总结
This study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women. The study will compare the herbal extract with a matching placebo. Approximately 100 women aged 45 to 60 years with menopausal symptoms will be enrolled, with approximately 80 expected to complete the study. Participants will take one study product daily for 8 weeks. Menopausal symptoms, including hot flashes, mood, sleep, skin health, and hair and scalp health, will be assessed using questionnaires, a daily hot flash diary, blood tests, and safety assessments.
详细描述
Menopause is associated with a range of symptoms that may substantially affect quality of life, including vasomotor symptoms such as hot flashes and night sweats, sleep disturbances, mood changes, and changes in skin and hair health. Although hormone therapy can be effective for menopausal symptoms, some women seek non-hormonal approaches.
This study is designed to evaluate a standardized herbal extract containing Shatavari with natural bio-enhancer ingredients as a potential non-hormonal approach for managing menopausal symptoms. The study will use a randomized, double-blind, placebo-controlled design to compare the test product with a matching placebo over an 8-week intervention period.
The primary evaluation will focus on changes in overall menopausal symptom burden and hot flash symptoms. Additional evaluations will examine depressive symptoms, sleep quality, self-reported skin health, and self-reported hair and scalp health. Safety and tolerability will also be monitored throughout the study.
Exploratory assessments will evaluate changes in selected inflammatory and hormonal biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), follicle-stimulating hormone (FSH), estradiol, and luteinizing hormone (LH). Changes in thigh and hip circumference will also be explored as anthropometric measures.
Participants will undergo screening, baseline/randomization, mid-study, and end-of-study assessments. Study-related information will be collected using validated questionnaires, participant diaries, laboratory assessments, vital signs, anthropometric measurements, and adverse-event monitoring. Participants will be followed for adherence to the study product and completion of study assessments.
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
- Double (Participant, Investigator)
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
- •Female subjects aged 45-60 years at screening.
- •Post-menopausal status, defined as no menstrual period for at least 12 months, graded as post-menopausal per STRAW classification (not due to pregnancy, lactation, or medical/surgical causes).
- •Menopause Rating Scale (MRS) score > 9 at screening.
- •Average frequency of hot flashes >= 3 per day for at least 7 consecutive days prior to screening.
- •Willing and able to provide written informed consent and comply with study procedures, including maintaining the daily hot-flash diary.
排除标准
- •Body mass index (BMI) <= 18 kg/m2 or > 35 kg/m
- •History of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or other sex hormone-related cancers.
- •History of uterine resection or hysterectomy.
- •Unexplained abnormal uterine bleeding occurring after >= 1 year of menopause.
- •History of severe migraine, or diagnosis of thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or history of coronary angioplasty within 1 year prior to screening.
- •Currently undergoing treatment for severe disease of the cardiovascular, immune, respiratory, gastrointestinal/hepatobiliary, renal/urologic, nervous, or musculoskeletal system, or for infectious disease or malignancy.
- •Psychiatric disorders: clinically diagnosed depression, anxiety disorder, or sleep disorder within 3 months prior to screening treated with medication, or current use of neuropsychiatric drugs.
- •Use of thyroid hormones, clonidine, anticoagulants, antiplatelet agents (e.g., warfarin, clopidogrel), or osteoporosis treatments within 3 months prior to screening.
- •Use of any medication or plant-based hormone-like extract for menopausal symptoms within 3 months prior to screening.
- •Continuous intake of health functional foods related to menopause or herbal medicine within 1 month prior to screening.
- •Uncontrolled hypertension (resting blood pressure >= 160/100 mmHg after 10 minutes of rest).
- •Uncontrolled diabetes (fasting blood glucose >= 180 mg/dL or HbA1c > 9.5%).
- •Excessive use of tobacco (>20 cigarettes/day), caffeine (>5 cups/day), or alcohol (>14 drinks/week) within 4 weeks prior to screening.
- •History of clinically reported drug abuse within 1 year prior to screening.
- •Known clinically significant hypersensitivity to any component or excipient of the investigational product.
- •Participation in another interventional clinical trial within 1 month prior to study start.
- •Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation.
研究组 & 干预措施
Shatavari Herbal Extract
Participants assigned to this arm will receive one 400 mg study capsule orally once daily for 8 weeks. The study product contains Shatavari (Asparagus racemosus) extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide, with a total capsule weight of 400 mg. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes.
干预措施: Shatavari (Asparagus racemosus) Extract (Dietary Supplement)
Placebo
Participants assigned to this arm will receive one matching placebo capsule orally once daily for 8 weeks. The placebo will be formulated to match the appearance and administration of the active study product. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Menopause Rating Scale (MRS) Total Score
时间窗: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in menopausal symptom severity from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Menopause Rating Scale (MRS). The MRS consists of 11 items covering somatic, psychological, and urogenital menopausal symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms), with a total score ranging from 0 to 44. Higher scores indicate greater severity of menopausal symptoms. A decrease in MRS total score indicates improvement in menopausal symptom burden.
Change in Average Daily Hot Flash Frequency
时间窗: Baseline Run-in Period (7 days before Day 0) to End-of-Study Assessment (Day 56 ± 5 days)
Change in average daily hot flash frequency from the baseline run-in period to the end of treatment. Hot flash frequency will be calculated as the mean number of hot flashes recorded per day during the 7-day baseline run-in period before Day 0 and during the assessment period at the end of treatment. A decrease in average daily hot flash frequency indicates improvement.
次要结局
- Change in Beck Depression Inventory-II (BDI-II) Score(Baseline (Day 0) to End of Study (Day 56 ± 5 days))
- Change in Athens Insomnia Scale (AIS) Score(Baseline (Day 0) to End of Study (Day 56 ± 5 days))
- Change in Self-Reported Skin Radiance Score(Baseline (Day 0) to End of Study (Day 56 ± 5 days))
- Change in Hair & Scalp CARE Questionnaire Total Score(Baseline (Day 0) to End of Study (Day 56 ± 5 days))