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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200006790

Enrollment

Unknown

Registered

2022-11-17

Start date

2022-12-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized anxiety disorder with insomnia

Interventions

Treatment group:Xiangxuan Anshen prescription

Controlled group:Placebo(10%Xiangxuan Anshen prescription)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
HAMA;	—

Secondary

Measure	Time frame
TCM Symptom List;ISI;PSQI;	—

Countries

China

Contacts

Public ContactSun Yongning

1276@szy.sh.cn18930177579

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026