Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Composite hot flash score: Frequency × Severity
研究概览
简要总结
The goal of this clinical trial is to learn if a daily nutritional supplement can reduce hot flashes and other menopausal symptoms in postmenopausal women.
The main questions this study aims to answer are:
Does the supplement reduce the number and severity of daily hot flashes?
Does it improve other common menopausal symptoms?
Researchers will compare the supplement to a placebo (a look-alike capsule with no active ingredients) to see if it helps manage symptoms during menopause.
Participants will:
Take either the supplement or a placebo daily for 30 days
Track their hot flashes each day using a short online survey
Complete a symptom questionnaire at the beginning and end of the study
This study is for women ages 40-60 who have been postmenopausal for at least one year and currently experience bothersome hot flashes.
详细描述
Purpose:
To evaluate the effectiveness of a nutritional supplement in reducing hot flash severity/frequency and menopausal symptoms in postmenopausal women.
Design:
Randomized, double-blind, placebo-controlled, two-arm, parallel-group trial over 30 days.
Participants:
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women aged 40-60 years.
- •Menopause Rating Scale score: (a) GE 14 and (b) score of 3 or 4 (severe to very severe) for hot flashes (Blumel et al., 2018).
排除标准
- •Current use of hormone therapy or other medications known to affect hot flashes.
- •Significant comorbidities that may interfere with study participation.
研究组 & 干预措施
Placebo Group: Sugar pill
干预措施: Shatavari Root Extract, oral capsule (Dietary Supplement)
Supplement Group
干预措施: Shatavari Root Extract, oral capsule (Dietary Supplement)
结局指标
主要结局
Composite hot flash score: Frequency × Severity
时间窗: 30 days
Frequency: Total number of hot flashes experienced that day. Hot Flash Severity: Rating of hot flashes on a 7-point severity scale (0 = none, 1 = very mild, 2 = mild, 3 = mild/moderate, 4 = moderate, 5 = severe, 6 = very severe)
次要结局
- Menopause Rating Scale(30 days)