Effects of Xiangshao Granules on Anxiety in Menopausal Women: A Multicenter, Randomized, Double-blind, Placebo-controlled Study.
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 18
- 主要终点
- Self-rating Anxiety Scale (SAS) scores change (%)
研究概览
简要总结
Symptoms of anxiety are prevalent during the menopausal transition and early postmenopause. These symptoms are mainly improved by anti-anxiety agents, which are associated with some adverse effects including dizziness, sleepiness, and constipation and not all patients respond to currently available pharmacological treatments, thus novel agents with fewer side effects are needed. Some studies have shown that traditional Chinese medicine can alleviate menopausal symptoms safely and economically, and improve quality of life. Xiangshao granules reportedly have good curative effects on menopausal symptoms and premenstrual syndrome and exhibit good safety. This study aim to evaluate the efficacy and safety of Xiangshao granule in improving anxiety state of women with menopause 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •meet the diagnostic criteria for menopause syndrome (age 40-65 years, being in the menopausal transition stage or postmenopausal stage determined according to the 2011 Stages of Reproductive Aging Workshop +10 criteria).
- •50 ≤ SAS scores ≤
- •improved Kupperman scores ≥
- •has an intact uterus and at least one ovary.
- •able and willing to participate in study and provide written informed consent, and agrees to follow all study requirements. The investigator consider the subject able to complete the study.
排除标准
- •history of allergy or sensitivity to investigational product.
- •currently or historically taking medication or psychotherapy for menopause anxiety in the past 4 weeks, including but not limited to estrogens, oestrogen-like hormone, Chinese medicine or health care products used to relieve anxiety (such as soy isoflavones, vitamin E, black cohosh), anti-anxiety agents, antidepressants, mood stabilizers, sedatives.
- •anxiety or other psychiatric disease unrelated to menopause (eg., currently or previously diagnosed as major depression, acute panic disorder, obsessive-compulsive disorder, phobia, hypochondria, mood disorder or schizophrenia or psychiatric diseases caused by other psychoactive substances or organic diseases), anxiety symptoms caused by stress, suicidal tendency, alcohol or drug dependence, etc.
- •having major depression as defined by a SDS score≥70 at screening.
- •systemic disease (eg., hypothyroidism/hyperthyroidism, unstable coronary heart disease, severe hypertension [sbp≥180mmHg and/or dbp≥110mmHg] or pheochromocytoma).
- •definite diagnosis of endometrial cancer, cervical cancer, ovarian cancer and other gynecological malignancies, as well as breast cancer.
- •severe liver or kidney diseases (eg., alanine aminotransferase[ALT]/aspartate aminotransferase[AST]/serum creatinine[Scr] levels 2 times greater than the upper limit of normal) or severe primary diseases in cardiovascular, cerebrovascular, liver, kidney and hematopoietic system.
- •participated in other clinical trials within the last 3 months.
- •lactating or pregnant women, or plan to become pregnant during study or not agree to use reliable contraceptive methods throughout the study period.
- •other reasons the investigator consider the patient may not be suitable for the study.
研究组 & 干预措施
Xiangshao Granules
dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks
干预措施: Xiangshao Granules (Drug)
Xiangshao Granules Placebo
dissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks
干预措施: Xiangshao Granules Placebo (Drug)
结局指标
主要结局
Self-rating Anxiety Scale (SAS) scores change (%)
时间窗: 8 weeks
% change in SAS scores after 8 weeks of treatment compared with baseline scores
次要结局
- serum FSH level(8 weeks)
- SAS scores change (%)(4 weeks)
- SDS scores change (%)(8 weeks)
- gastrointestinal symptom score (GIS) change (%)(8 weeks)
- serum Follicle Stimulating Hormone (FSH) level(4 weeks)
- serum estradiol (E2) level(8 weeks)
- Kupperman scores change (%)(8 weeks)
- Self-rating Depression Scale (SDS) scores change (%)(4 weeks)