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Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have increased the generation of overweight or obesity. There is correlation between obesity, diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular disorders. Cassia seed is one of traditional Chinese herbs, that can decline blood lipedema effect. Therefore, the purpose of the present study was to design a randomized, double blind, control group study to assess the therapeutic effect of Cassia seed in schizophrenia patients with obesity.
Total of 92 schizophrenia patients with obesity will be enrolled and divided randomly into: 1) case group, received oral administration of Cassia seed (3.0g), once/day, 12 weeks; 2) control group, received oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia), 12 weeks. The primary outcome included the changes of body mass index (BMI), waist circumferences (WC); secondary outcome measured included the changes of hemoglobin A1c (HbA1c), total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, CRP (C-Reactive protein), IL-6, systolic blood pressure, diastolic blood pressure, and meridian energy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cassia seed | Experimental | oral administration of Cassia seed (3.0g), once/day for 12 weeks |
|
| Cassia seed placebo | Placebo Comparator | oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cassia seed tablet | Drug | traditional Chinese herbs |
|
| Measure | Description | Time Frame |
|---|---|---|
| physiological parameter for measuring Height and weight | the parameter of BMI in kg/m^2 for exploring the changes of body mass index (BMI) after cassia obtusifolia treatment | 12 weeks |
| sphygmomanometer | the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood analyzer | the concentration of lipid profile, including total cholesterol, triglyceride, high denisty lipoprotein and low density lipoprotein after cassia obtusifolia treatment. | 12 weeks |
| Meridian energy skin conductivity assessment using amperometer (0-200uA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| For-Wey Lung, MD, ScD | Calo Psychiatric Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calo Psychiatric Center | Pingtung City | Others | 925 | Taiwan |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
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Total of 92 schizophrenia patients with obesity was divided randomly into: 1) control group, received oral administration of Cassia seed placebo (3.0g), once/day for 12 weeks continuously; 2) treatment group, received oral administration of Cassia seed (3.0g), once/day for 12 weeks continuously.
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All participants are randomized into treatment or placebo group. Investigator also did not know who are in which group.
the parameter of meridian energy after cassia obtusifolia treatment |
| 12 weeks |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |