A randomized, double-blind, controlled clinical trial of Suhe Granules for chronic insomnia patients with Disharmony of Qi and Blood and Deficiency of Heart and Kidney

Guangdong Provincial Hospitai of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(1) 18 years old or older;
•(2) Meet the diagnostic criteria for chronic insomnia of International Classification of Diseases-11(ICD-11);
•(3) Meet the diagnostic criteria of Shuhe Granules:
•Cold or wind intolerance, daytime mental fatigue, palpitations or dizziness, pale lower eyelids or red at the edge of lower eyelids, low menstrual flow and cold hands;
•(4) Signed the informed consent form;

•(1) Meet any criteria of the eliminating symptoms
•eliminating symptoms:
•a. The lower eyelid is completely red
•b. Hand baking heat
•c. The stool is dry and(or) hard
•d. The moss is thick or dry and rough
•e. The pulse-to-breath ratio is greater than 5
•(2) People who are preparing to become pregnant or pregnant or breastfeeding, or who need to accompany their children to sleep;
•(3) According to the medical history and consultation, the doctor confirms that 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, etc.;
•(4) Diagnosis of severe depression patients according to the Patient Health Questionnaire-9 (PHQ-9)(total score =15);
•(5) Diagnosis of patients with severe anxiety according to the Generalised anxiety disorder-7(GAD-7)(total score =15);
•(6) Those who have participated in clinical trials of other drugs in the past 30 days;
•(7) Patients with other mental illnesses

发起方

Guangdong Provincial Hospitai of Chinese Medicine