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

Phase 1

• Conditions: Generalized anxiety disorder with insomnia

• Registration Number: ITMCTR2200006790
• Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HAMA;

Secondary Outcome Measures

Name	Time	Method
TCM Symptom List;ISI;PSQI;