To Evaluate the Efficacy and Safety of Earthful Women 40 plus Supplement in Menopause Symptom Management and Quality of Life improvement in Perimenopause and Postmenopausal (Menopause) Women.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Changes in global scores of Menopausal Rating Scale (MRS). .The MRS Scale Measures the following parameters: (11 points - hot
研究概览
简要总结
Menopausal symptoms severely reduce the quality of life of post-menopausal women worldwide. Nutraceuticals are widely prescribed as a viable and safer alternative and complementary approach to standard therapies. The aim of this study was to evaluate the clinical efficacy and safety of a nutraceutical in post-menopausal women.
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
- •Perimenopausal women and postmenopausal women in the age group of 40 to 65 years.
- •Participants who are apparently healthy.
- •Women who have at least 5 points of MRS score.
- •Calcium deficiency Biomarkers.
排除标准
- •Perimenopausal women and postmenopausal women in the age group of 40 to 65 years.
- •Participants who are apparently healthy.
- •Women who have at least 5 points of MRS score.
- •Calcium deficiency Biomarkers.
结局指标
主要结局
1.Changes in global scores of Menopausal Rating Scale (MRS). .The MRS Scale Measures the following parameters: (11 points - hot
时间窗: 1. (Day 0, Day30, Day | 60 & Day 90) | 2.Day 0 & Day 90
flashes, mood swings , anxiety, fatigue ,Body pains,sleep disturbances, vaginal
时间窗: 1. (Day 0, Day30, Day | 60 & Day 90) | 2.Day 0 & Day 90
dryness)
时间窗: 1. (Day 0, Day30, Day | 60 & Day 90) | 2.Day 0 & Day 90
2. Calcium Biomarkers
时间窗: 1. (Day 0, Day30, Day | 60 & Day 90) | 2.Day 0 & Day 90
次要结局
- 1. Change in the frequency and severity of hot flushes(2. Change in the frequency and severity of night sweats.)
研究者
Dr Sanjana Kumari Vt
Sri Lakshmi Hospital