A randomized, double-blind, controlled clinical study of Shuhe Granules in the treatment of chronic insomnia disorder

Guangdong Provincial hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•(1) Aged 18-70
•(2) In line with Western medicine chronic insomnia diagnostic standards
•It is consistent with the diagnostic criteria of chronic insomnia in the new edition of International Classification of Sleep Disorders? formulated by the American Academy of Sleep Medicine
•(3) Consistent with the indications of Shuhe granules:
•Both of the following three
•a. sleep difficulty factor score of Pittsburgh Sleep Quality Index =1
•b. daytime function factor score of Pittsburgh Sleep Quality Index =1
•c. Dizziness, palpitation, low menstrual volume, spontaneous sweating, fear of wind, cold limbs, white tongue, pale face, pale or reddish eyelids (symptoms =3/8).
•None of the following cannot appear at the same time
•a. The lower eyelid is completely red
•b. Warm hands
•c. Dry, stiff stool
•d. Thick and greasy or dry and rough moss
•e. Pulse ratio greater than 5.5
•(4) Sign informed consent

•1.Preparing to become pregnant or during pregnancy or lactation;
•2. Secondary insomnia caused by physical disease. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc.
•3. Secondary insomnia caused by mental disease. For example: Affective disorders, anxiety disorder, depression, schizophrenia, and any other serious mental disorders.
•4. A Patient health questionnaire-9 (PHQ-9) score of 15 or higher;
•5. A Generalized Anxiety Scale (GAD-7) score of 15 or higher
•6. Use of medicine to treatment sleeping disorders in the past two week.
•7.Participants in clinical trials of other drugs in the past 30 days;

发起方

Guangdong Provincial hospital of Traditional Chinese Medicine