ITMCTR2200005639已完成1 期
A randomized, double-blind, parallel controlled clinical study of tangerine peel enzyme in the treatment of insomnia with deficiency of heart and spleen
Guangdong Hospital of traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
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
- 性别
- All
入选标准
- •(1) Over 18 years old.
- •(2) The diagnosis of chronic insomnia meets the Western medical standard.
- •(3) It meets the standard of deficiency syndrome of heart and spleen in traditional Chinese medicine.
- •(4) Pittsburgh sleep quality index (PSQI) total score > 7
- •(5) Sign informed consent
排除标准
- •(1) People who are ready for pregnancy or during pregnancy or lactation or need to sleep with their children.
- •(2) According to the medical history and consultation, the doctor confirmed the secondary insomnia caused by other diseases.
- •For example: local pain, restless legs syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis
- •(3) Patients with moderate and severe depression (total score = 10) were diagnosed according to the patient's self rating depression tool (PHQ-9)
- •(4) Patients with moderate and severe anxiety were diagnosed according to GAD-7 (total score = 10)
- •(5) According to the medical history and consultation, the doctor confirmed that the patient needs to be managed according to the disease management mode.
研究者
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