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A multicenter randomized, double-blind, controlled trial for efficacy of YueJu Pills in the treatment of antidepressant

A multicenter randomized, double-blind, controlled trial for efficacy of YueJu Pills in the treatment of antidepressant

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025532
Enrollment
Unknown
Registered
2019-08-31
Start date
2019-09-03
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

Depression

Interventions

Sponsors

Zhongda Hospital affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for DSM-V or ICD-10 depression; 2. Aged 18-65 years old; 3. Patients with mild to moderate depression, Hamilton Depression Scale (24 items) score 35 points = HAMD-24 = 20 points; 4. In the past 1 week, there have been no Chinese medicines used to treat depression (including Chinese medicine and decoction), western medicine (fluoxetine, escitalopram, venlafaxine, etc.), or in the short term (3-5) Those who have taken the above drugs within days) have been discontinued for more than 7 days; 5. Willing to accept 42 days of treatment, the subject informed consent, and signed informed consent; 6. Both are right-handed and emmetropia.

Exclusion criteria

Exclusion criteria: 1. Patients with suicidal depression, the score of the third item of Hamilton Depression Scale = 2 points; 2. People who are suffering from mental illness other than depression, as well as those caused by external environmental disturbances or traumatic brain injury; 3. Pregnant or lactating women; 4. A history of drug allergy; 5. Under 18 years of age or 65 years of age or older; 6. Combined with severe primary diseases such as cardiovascular, pulmonary, liver and kidney and hematopoietic system, and patients with severe brain organic diseases and mental illness; 7. Alcohol and/or psychoactive substances, drug abusers and dependents (including sleeping pills); 8. Does not meet the inclusion criteria, does not use the drug according to the regulations, can not judge the efficacy or incomplete data, affecting the efficacy and safety judgment; 9. Unable to understand scale content due to lack of consciousness, language barriers, and intellectual and cultural level; 10. Left hand; 11. During the elution period (within 7 days), the patient's depressive symptoms return to a healthy state, that is, the Hamilton Depression Scale score = 20 points after the end of the elution period; 12. Those who have been depression for more than 2 years.

Design outcomes

Primary

MeasureTime frame
HAMD-24;HAMA;TCM constitutional judgment classification scale;coated tongue;MRI;

Secondary

MeasureTime frame
MADRS;QIDS-SR16;PHQ-9;

Countries

China

Contacts

Public ContactCHEN GANG

Jinan University

chengang@jnu.edu.cn+86 17701991758

Outcome results

None listed

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