Phase 3 Study - Efficacy and Tolerance for the Mixture of Dry Extracts Black Cohosh and Saint John's Worth Versus Isolated Black Cohosh Extract for the Climacteric Symptoms' Control
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Menopause Rating Scale
研究概览
简要总结
Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.
详细描述
2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life.
The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator.
This protocol was performed for the best of our volunteers.
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)
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
- •Climacteric women 45-60 years old - pre and postmenopausal
- •Climacteric complains for at least 3 months
- •No treatments for at least 2 months
- •MRS score 0.4 or more for at least 3 items
- •Hamilton's Scale score from 15-23
排除标准
- •Hormon Therapy or any other for the last 3 months
- •Antidepressive and Hypnotic medication for the last 3 months
- •Sever illness (cardiac, hepatic, renal, digestive or metabolic) or TSH alteration
- •History for allergies and hipersensitivity to any component of the drugs formulations
- •No knowledge for reading or writing
- •Suicide risk
研究组 & 干预措施
Cimicifuga+Hiperico
80 + 450 mg / tablet
干预措施: Cimicifuga + Hiperico (Drug)
Cimicifuga Herbarium
80 mg / caps
干预措施: Cimicifuga Herbarium (Drug)
Aplause®
20 mg / tablet
干预措施: Aplause® (Drug)
结局指标
主要结局
Menopause Rating Scale
时间窗: 8 months
Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale\*
次要结局
- Hamilton's Depression Scale(8 months)
- WHOQOL(8 months)
- Health Numbers(8 months (T-2 to T6))