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Research on the development of in-hospital preparations for the treatment of GAD with Huangqi Renshen Wan for spleen deficiency and dampness and heat

Research on the development of in-hospital preparations for the treatment of GAD with Huangqi Renshen Wan for spleen deficiency and dampness and heat

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001142
Enrollment
Unknown
Registered
2025-06-09
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Generalized Anxiety Disorder

Interventions

Huangqi Renshen Wan Group:Huangqi Renshen Wan
Conventional Western Medicine Group:sertraline
Huangqi Renshen Wan + Conventional Western Medicine Group:Huangqi Renshen Wan+sertraline

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: (1) Meet diagnostic criteria for generalized anxiety disorder (GAD); (2) Conform to diagnostic standards for spleen deficiency with dampness-heat syndrome; (3) Aged between 18 and 65 years; (4) Stable vital signs; (5) Clear consciousness; age-appropriate appearance; intact orientation; coherent thought processes; absence of hallucinations; no delusional ideation; congruent affect; no significant memory impairment; preserved intellectual functioning; retained insight.

Exclusion criteria

Exclusion criteria: (1)Severe anxiety and/or severe depression: SAS score >69 SDS score >72; (2)Symptoms potentially caused by substance dependence or common medical conditions (e.g. alcohol dependence hyperthyroidism diabetes coronary artery syndrome pheochromocytoma); (3)Severe psychiatric disorders including manic episodes bipolar disorder organic psychosis schizophrenia schizoaffective disorder persistent delusional disorder (paranoid psychosis) epilepsy-induced mental disorders or intellectual disability with comorbid psychiatric disorders; (4)Meeting ICD-10 diagnostic criteria for major depressive disorder with clear suicidal tendencies or a history of suicide attempts; (5)Discontinuation of CNS depressants/stimulants within 1 month or discontinuation of antidepressants/anxiolytics within 1 month; (6)Pregnant or lactating women or individuals with plans to conceive during the trial period; (7)Participation in other clinical trials within the past 3 months; (8)Patients with known allergies to the investigational drug; (9)Individuals weighing less than 40 kg.

Design outcomes

Primary

MeasureTime frame
Self-Rating Anxiety Scale;

Secondary

MeasureTime frame
Cornell Medical Index;Pittsburgh sleep quality index;Self-rating depression scale;

Countries

China

Contacts

Public ContactYan Li

Guangdong Provincial Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine)

janeliyan2018@163.com+86 189 2210 8342

Outcome results

None listed

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