ITMCTR2000003639尚未招募1 期
Effect Evaluation of Cai's Shugan Kaiyu Decoction combined with Traditional Chinese Medicine Music Therapy on Anxiety and Depression of Menopause Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 40 至 55（—）
- 性别
- Female
入选标准
- •1. According to the diagnostic criteria of Western Medicine (menopause syndrome, refer to the diagnostic criteria for menopause syndrome in obstetrics and gynecology (9th Edition)):
- •(1) women aged 40-55 years old;
- •(2) menstrual disorders;
- •(3) hot flashes, sweating, restlessness, depression or irritability, insomnia and other clinical manifestations;
- •(4) FSH > 10u / L;
- •2. According to the diagnostic criteria of traditional Chinese medicine (referring to gynecology of traditional Chinese medicine (edited by Zhang Yuzhen, New Century Edition) and the diagnostic criteria of liver qi stagnation of various syndromes before and after menopause issued by the State Administration of traditional Chinese medicine. Main symptoms: menstrual disorders or shut-down, depression, sadness, good too rest, like sad to cry or irritable, anxious. Secondary symptoms: hot flashes and sweating, palpitation, insomnia and dreaminess, chest fullness, less abdominal distension and pain, dry mouth, pharyngeal infarction, and constipation. Tongue vein: the tongue is light red or red, with thin white or less moss, and the pulse is thin, stringy or deep. The above main symptoms must have, and 2 or more symptoms in the secondary symptoms can be diagnosed by combining tongue and pulse;
- •3. According to the diagnostic criteria of anxiety and depression (refer to the diagnostic criteria of expert consensus on diagnosis and treatment of anxiety and depression in general hospital. Anxiety state: it is a group of symptomatic syndromes, including physical and mental anxiety symptoms, as well as restlessness and other sports anxiety symptoms. Individuals have emotional experience inconsistent with the situation, and can be accompanied by sleep difficulties, anxiety and irritability. Depressive state: it is a group of symptomatic syndrome, mainly characterized by significant depression, loss of interest or pleasure, showing emotional, behavioral and physical symptoms, lasting for a long time, and serious cases may have suicidal thoughts, etc.);
- •4. Women aged 40-55 years with Kupperman score >= 15;
- •5. HAMA (14 items) score >= 7 points, < 24 points; HAMD (17 items) score >= 7 points, < 29 points;
- •6. No serious organic diseases and other mental diseases, and can cooperate with the treatment;
- •7. Those who did not take hormone drugs or psychotic drugs in the past 3 months;
- •8. Patients' informed consent and voluntary participation;
- •9. Sign written informed consent.
排除标准
- •1. Patients with family genetic history, anxiety disorder and depression before perimenopause;
- •2. Those with severe mental symptoms or suicidal tendency;
- •3. Those who have used hormone drugs or psychotic drugs in recent 3 months;
- •4. Patients with other mental disorders, such as anxiety and depression caused by psychoactive substances and non addictive substances;
- •5. Patients complicated with cardiovascular, liver, kidney, immune system, hematopoietic system and other serious diseases, as well as other organ system dysfunction.
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