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Clinical study of Yueju pill combined with olanzapine in the treatment of negative symptoms of schizophrenia

Phase 1
Not yet recruiting
Conditions
Schizophrenia
Registration Number
ITMCTR2100005104
Lead Sponsor
Mental Health Center, Shanghai Jiao Tong University School of Medicine
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 of the International Classification of Diseases (ICD-10) for schizophrenia;
2. In line with the dialectical treatment of epilepsy syndrome of liver-qi stagnation and phlegm-qi stagnation in TCM internal medicine;
3. Take olanzapine before entering the group, the dose will be stable for more than 2 weeks, and the treatment plan will remain unchanged during the study period;
4. Positive and Negative Psychiatric Symptom Scale (PANSS) > 60 points, and Negative Symptom Scale (SANS) total score >= 50 points at the time of enrollment;
5. Gender is not limited, aged 18-65 years;
6. The informed consent form for participating in this study shall be signed by the subjects themselves or their legal guardians.

Exclusion Criteria

1. Serious physical disease, organic brain disease, traumatic brain injury, etc.;
2. Psychotic symptoms secondary to other physical diseases;
3. There is a clear risk of suicide or endangerment to self or others;
4. Patients with Yin deficiency and internal heat type diagnosed by TCM pulse diagnosis;
5. Two or more items >= 4 points (P1, P3, P5, P6, G9);
6. Calgary Schizophrenia Depression Scale total score > 6;
7. The sum of the first 8 items on the Simpson Angus Scale (SAS) is >3;
8. Meets ICD-10 diagnosis of any other psychiatric disorder.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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