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In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia.
This study is an open lable clinical intervention trial, include 30 female subjects with diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine( 300mgTID) as an add-on therapy lasting 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| berberine adjunctive group | Experimental | Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| berberine | Drug | berberine 300mg TID add-on for berberine adjunctive group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of FBG | Serum fasting biood glucose | Change from Baseline serum fasting biood glucose at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of TG | Serum triglyceride | Change from Baseline serum triglyceride at 8 weeks |
| Change of LDL | Serum low density lipoprotein | Change from Baseline serum low density lipoprotein at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Anding Hospital | Tianjin | Tianjin Municipality | 300222 | China |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Change of BP | Systolic blood pressure | Change from Baseline Systolic Blood Pressure at 8 weeks |
| Change of waist | Waistline | Change from Baseline waistline at 8 weeks |
| Change of BP | Diastolic blood pressure | Change from Baseline Diastolic Blood Pressure at 8 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |