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Berberine is an isoquinoline alkaloid extracted from medicinal herbs, has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, fewer study reported its modification on lipid metabolism in schizophrenia. Metformin, have been used for metabolic abnormalities in schizophrenia, findings from these studies indicated that they did have some effect,which are still in experimental stage.This study is aim to compare the efficacy and safety of berberine and metformin for preventing metabolic dysfunction in schizophrenia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine group | Experimental | Berberine 300mg（three times a day） plus Metformin simulant 250mg（three times a day）agent plus any atypical antipsychotic drug Metformin simulant were matched to metformin in shape, smell and colour were sealed in identical bottles |
|
| Metformin group | Active Comparator | Metformin 250mg（three times a day） plus Berberine simulant 250mg（three times a day）agent plus any atypical antipsychotic drug Berberine simulant were matched to Berberine in shape, smell and colour were sealed in identical bottles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Drug | The patients will randomly assigned to receive berberine (900 mg day-1, three times a day) and metformin simulant（750mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Fasting blood samples for Fasting blood glucose(FBG) | The main objective is to compare Berberine with Metformin on the effect of reducing the levels of FBG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Changes of Triglyceride(TG) | The main objective is to compare Berberine with Metformin on the effect of reducing the levels of TG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Changes of High-Density Lipoprotein (HDL) | The main objective is to compare Berberine with Metformin on the effect of reducing the levels of HDL in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Changes of Waist circumference(WC) | The main objective is to compare Berberine with Metformin on the effect of reducing the levels of WC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Changes of Blood pressure (BP)，including systolic and diastolic pressure | The main objective is to compare Berberine with Metformin on the effect of reducing the levels of systolic or diastolic pressure in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Body mass index(BMI) | Compare Berberine with Metformin on the effect of reducing the levels of BP in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Changes of Positive and Negative Syndrome Scale（PANSS）scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Li, PHD | Contact | 022-88188006 | tjlijie3827@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Anding Hospital | Recruiting | Tianjin | Tianjin Municipality | 300222 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Metformin | Drug | The patients will randomly assigned to receive metformin (750 mg day-1, three times a day) and berberine simulant（900mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy |
|
Positive and Negative Syndrome Scale（PANSS）has been used to assess symptom severity in schizophrenia.Of the items included in PANSS ,seven constitute a Positive scale,seven form a Negative scale and sixteen constitute a General Psychopathology scale.7-point rating instrument was conceived.A total Score is computed three subscales.Minimum scores is 30 and maximum scores is 210.The higher score are considered the psychiatric symptoms more serious.Compare Berberine with Metformin on the effect of reducing the levels of the scores of PANSS in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment |
| 0, 4, 8,12 weeks |
| Changes of Total Cholesterol(TC) | Compare Berberine with Metformin on the effect of reducing the levels of TC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Changes of C reactive protein | Compare Berberine with Metformin on the effect of reducing the levels of C reactive protein in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α) | Compare Berberine with Metformin on the effect of reducing the levels of Interleukin-1β,Interleukin-6,tumor necrosis factor in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment | 0, 4, 8,12 weeks |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |