Xiangxuan Anshen prescription in the treatment of generalized anxiety disorder with insomnia: a randomized, double-blind, placebo-controlled study

Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of TCM0 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) Male and female, age (18-83 years); (2) The diagnostic criteria of western medicine refer to the diagnostic criteria of generalized anxiety disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders), accompanied by insomnia with difficulty falling asleep or difficulty maintaining sleep as the main symptom. (3) HAMA > 14; (4) PSQI > 5; (5) Not taking antidepressants, anti-anxiety drugs or sedative and hypnotic drugs in the past 2 weeks; (6) Sign written informed consent. (7)It conforms to one of the syndrome differentiation types of anxiety disorder in the series of teaching materials of TCM mental diseases Mental Diseases Therapy of Integrated Chinese and Western Medicine.

•(1) Exclusion of anxiety symptoms caused by other physical diseases (such as hyperthyroidism, oncocytoma, etc.), or substances/drugs (such as drug abuse, exposure to toxins, excessive consumption of coffee or alcohol);(2) Exclusion of other types of anxiety disorders (such as social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, etc.); 3) Women who are pregnant, breastfeeding, or at risk of becoming pregnant in the study and cannot use effective contraception;(4) The function of heart, liver, kidney, nervous system and other systems is impaired;(5) Hamilton Depression Scale (HAMD-17) > 17; (6) Laboratory tests and electrocardiogram tests have obvious clinically significant abnormalities, which may affect the drug evaluation or subject safety;(7) AST and ALT exceeded 3.0 times of the upper limit of normal value; (8) Participated in other clinical drug investigators within the last month.

发起方

Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of TCM