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Randomized double-blind placebo-controlled trial of Jianpijieyu Prescription in the treatment of mild to moderate depressio

Not Applicable
Conditions
depression
Registration Number
ITMCTR2200006729
Lead Sponsor
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1) Meet the diagnostic criteria for DSM-V depression;
2) According to the TCM syndrome differentiation, it is the syndrome of deficiency of heart and spleen or stagnation of liver qi;
3) Men and women aged 18-65;
4) 17 items of Hamilton Depression Scale (HAMD) score =18 and =24, and one item of depression in HAMD score =2;
5) The subject agrees and signs the informed consent form.

Exclusion Criteria

1) Suicidal, HAMD suicide =2 points;
2) Hamilton Anxiety Scale (HAMA) score =29 for patients with severe anxiety symptoms;
3) Patients with serious or unstable heart, liver, kidney, endocrine, blood and other internal diseases;
4) Depressive episodes secondary to physical diseases;
5) Organic mental disorders, schizophrenia, bipolar disorder;
6) Depressive disorders caused by psychoactive substances (e.g., alcohol, tobacco, opioids, etc.) and non-addictive substances;
7) Have taken sedative, hypnotic, anti-depressant and other psychiatric drugs (such as risperidone and olanzapine) within one month;
8) Diabetic patients;
9) Allergic to the drug in this study;
10) Pregnant or lactating women;
11) Those who have received other clinical trials for depression in the past 3 months;
12) Those who are receiving targeted drug therapy.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
HAMD-17;
Secondary Outcome Measures
NameTimeMethod
HAMA;TCM syndrome integration;SDS;
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