Clinical Trial on the Treatment of Menopausal Syndrome With Chinese Medicine Gui-zhi-fu-ling-wan With Variation and the Mechanism of Anti-inflammation and Body Surface Temperature Distribution
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Greene Climacteric Scale (Chinese version)
研究概览
简要总结
This is a double-blinded, randomized, placebo-controlled clinical trial. Subjects will be randomly assigned to the treatment group (Modified Guizhi Fuling granules) or placebo group (Placebo granules) for 8 weeks. Outcomes will be measured at week 8 and week 12.
详细描述
Menopausal syndrome is a series of symptoms caused by ovarian follicles degeneration that occurs before or after menopause. These symptoms include central nervous system-related disorders (such as hot flashes, insomnia, depression, anxiety, etc.); metabolic, weight, cardiovascular and musculoskeletal changes; urogenital and skin atrophy; and sexual dysfunction.
Some previous studies have investigated the possibilities of using traditional Chinese medicine (TCM) for the treatment of menopausal syndrome. However, due to the limitations of previous clinical research, more evidence is required to support the efficacy of TCM treatment. Therefore, we propose to conduct a randomized, double-blinded, placebo-controlled clinical trial here, with the hope of objectively assessing the efficacy and safety of using TCM to treat menopausal syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects with age between 40 and 60 years old;
- •For those who have symptoms of primary menopause (irregular menstruation lasting for more than 6 months, or absence of menstrual periods for more than 3 months)
- •The score of the physical symptoms in Greene Climacteric Symptom Score (GCS) is 6 or above (average level);
- •Have moderate level (affecting certain level of daily activity) or severe (cannot carry out daily activity) hot flashes, defined as transient sensations of heat, sweating, flushing, anxiety and chills lasting for 1-5 minutes;
- •Diagnosed Deficiency of Kidney essence and static blood in Lower Jiao by Chinese medicine practitioner
- •Agreed to receive Chinese medication or placebo for 2 months upon randomization.
排除标准
- •The menopausal syndrome caused by surgical operations or medications (such as chemotherapy, gonadotropin-releasing hormone agonists, etc.).
- •Have received estrogen treatment in the past 2 months;
- •Have received any medication for treating menopause in the past month, including herbs, non-prescribed drugs, supplements, or change of diet to consume more legumes;
- •Known serious emotional, mental or psychological disorders that may affect the study;
- •During pregnancy, pre-pregnancy period, or lactation period;
- •Known history of allergy to any traditional Chinese medicine;
- •Have received anticoagulant or antiplatelet drugs in the past month;
- •Known history of some certain serious medical disease, such as cardiovascular disease, liver or renal dysfunction, diabetes, cerebrovascular disease, blood disorders, with unstable conditions;
- •Chinese medicine pattern combined with damp phlegm or damp heat, or only deficiency of Yin blood or absence of static blood pattern.
研究组 & 干预措施
Traditional Chinese medicine treatment group
Chinese medicine will be administered to patients in this group.
干预措施: Modified Guizhi Fuling granules (Drug)
Placebo group
Placebo will be administered to patients in this group.
干预措施: Placebo (Other)
结局指标
主要结局
Greene Climacteric Scale (Chinese version)
时间窗: Week 8
Greene Climacteric Scale (GCS) is one of the most common scales used to assess menopause. It includes four aspects of symptoms: vasomotor, somatic, psychological, and sexual response. This scale consists of 21 symptoms that can be assessed by patients themselves. The scoring from 0 to 3 in each item, indicates 'Not at all', 'A little bit', 'Much', and 'Very much' respectively.
次要结局
- Level change of sex hormones(Week 12)
- Greene Climacteric Scale (Chinese version)(Week 12)
- Temperature change of face, limbs and abdomen(Week 12)
- Short-Form Health Survey, SF-12v2 (Chinese version)(Week 12)
- Level change of inflammatory markers(Week 12)
研究者
Zhang Hongwei
School of Chinese Medicine
Chinese University of Hong Kong