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Study on Evaluation and Optimization of TCM Regimen of Generalized Anxiety Disorder

Study on Evaluation and Optimization of TCM Regimen of Generalized Anxiety Disorder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042211
Enrollment
Unknown
Registered
2021-01-15
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Generalized Anxiety Disorder

Interventions

Classical prescription + western medicine placebo group (liver depression and fire type):Take Danzhi Xiaoyao granule and buspirone placebo in the morning and evening respectively.
Traditional Chinese medicine empirical prescription + western medicine placebo group (liver depression and fire type):Take Anshen Jielv granule and buspirone placebo in the morning and evening respect
Western medicine + placebo of traditional Chinese medicine (liver depression and fire type):Take buspirone and Danzhi Xiaoyao powder placebo in the morning and evening respectively.
Classical prescription + western medicine placebo group (internal obstruction type of blood stasis):Take Xuefu Zhuyu granule and buspirone placebo in the morning and evening respectively.
Traditional Chinese medicine empirical prescription + western medicine placebo group (internal obstruction type of blood stasis):Take Huoxue Changzhi granule and buspirone placebo in the morning and e
Western medicine + placebo of traditional Chinese medicine (internal obstruction of blood stasis):Take buspirone and Xuefu Zhuyu placebo in the morning and evening respectively.
Classical prescription plus western medicine placebo group (heart gallbladder qi deficiency type):Take Anshen Dingzhi granule and buspirone placebo in the morning and evening respectively.
Traditional Chinese medicine empirical prescription + western medicine placebo group (heart gallbladder qi deficiency type):Take Dingzhi Wuyou granule and buspirone placebo in the morning and evening
Western medicine + placebo of traditional Chinese medicine (heart-gallbladder qi deficiency type):Take buspirone plus tranquilizer placebo in the morning and evening respectively.

Sponsors

Xuanwu Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-65 years; 2. Patients with anxiety disorder in accordance with clinical research standards; 3. Subjects who meet the TCM syndrome standards of liver stagnation and fire transforming type, blood stasis and internal resistance type, heart and gallbladder Qi deficiency type; 4. Subjects with stable vital signs have clear mind and certain expression ability; 5. The subjects who signed the informed consent agreed to participate in this study; Only those who meet the above five criteria can be selected.

Exclusion criteria

Exclusion criteria: 1. Patients with somatic diseases secondary to GAD; 2. Subjects with unstable vital signs; 3. Subjects with severe aphasia, agnosia and inability to communicate; 4. Subjects with anxiety accompanied by other mental diseases (such as depression, obsession, schizophrenia, etc.) diagnosed by western medicine; 5. Known alcoholics or substance dependent subjects; 6. Patients with non anxiety psychosis diagnosed by western medicine; 7. Subjects who used other drugs or therapies to treat anxiety disorder during the trial; 8. Subjects who did not use drugs according to the regulations were unable to judge the efficacy or incomplete information, which affected the efficacy or safety judgment; 9. Subjects who refused to take traditional Chinese medicine and had suicidal behavior; 10. Subjects who had received anti anxiety treatment within one week before the trial; 11. Subjects with severe hepatic and renal insufficiency; 12. Pregnant and lactating women; Those meeting one of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Hamilton anxiety scale, HAMA;Evaluation form of TCM Syndromes of Generalized anxiety Disorder;—

Secondary

MeasureTime frame
Montreal Cognitive Assessment, MoCA;Hamilton Depression Scale,HAMD-17;WHOQOL-Bref;—

Countries

China

Contacts

Public ContactMiao Qu

Xuanwu Hospital of Capital Medical University

qumiaotcm@126.com+86 13621104599

Outcome results

None listed

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