Clinical efficacy and safety of Kaiyuzhishen Decoction in the treatment of mild to moderate depression

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300077377

Enrollment

Unknown

Registered

2023-11-07

Start date

2022-12-01

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

major depressive disorder

Interventions

The paroxetine group:paroxetine

Low dose Kaiyuzhishen Decoction group:Low dose Kaiyuzhishen Decoction

High dose Kaiyuzhishen Decoction group:High dose Kaiyuzhishen Decoction

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of DSM-5 or ICD-10 for depression; 2. Aged 18-65 years; 3. Patients with depression, 17= HAMD-17=24; 4. Those who have not used traditional Chinese medicine (including Chinese patent medicine and decoction of mind relaxant) or western medicine (fluoxetine, paroxetine, escitalopram oxalate, venlafaxine, etc.) for depression in the past one week; 5. If the subject is willing to accept treatment for 42-56 days, the subject shall give informed consent and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Under the age of 18 or over the age of 65; 2. Suffering from mental diseases other than depression, external environmental interference factors or craniocerebral trauma; 3. Pregnant or lactating women; 4. Patients with a history of drug allergy; 5. Patients with major suicidal depression, i.e. those with the third item of Hamilton Depression Scale score greater than or equal to 2; 6. Patients with severe primary diseases of cardiovascular, lung, liver, kidney and hematopoietic system, severe organic brain diseases and mental disorders; 7. Alcohol and/or psychoactive substances, drug abusers and dependants (including sleeping pills); 8. Patients who did not meet the inclusion criteria, did not use drugs according to the regulations, could not judge the efficacy or had incomplete data that affected the judgment of efficacy and safety; 9. Unable to understand the content of the scale due to consciousness, language barriers, and insufficient intelligence and education level.

Design outcomes

Primary

Measure	Time frame
scores of different scales;	—

Countries

China

Contacts

Public ContactYonggui Yuan

ZhongDa Hospital, School of Medicine, Southeast University

yygylh2000@sina.com+86 139 1393 9082

Outcome results

None listed

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