Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: cassia seed tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 65 years diagnosed as schizophrenia at least more 6 months no major systemic illnesses based on physical examinations and laboratory test results BMI >= 24, WC >= 80 cm in female, WC >= 90 cm in male Exclusion Criteria: participants were pregnant and lactating women allergy to Cassia SGOT or SGPT more than 2 times normal level BUN or creatinine more than normal level Fasting blood glucose (serum) > 140 mg/dL, systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg, serum triglyceride > 400 mg/dL

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cassia seed<br>oral administration of Cassia seed (3.0g), once/day for 12 weeks | Drug: cassia seed tablet<br>* traditional Chinese herbs<br>* Other names: cassia obtusifolia;|
| Placebo Comparator: Cassia seed placebo<br>oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks | Drug: cassia seed tablet<br>* traditional Chinese herbs<br>* Other names: cassia obtusifolia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | the parameter of meridian energy after cassia obtusifolia treatment | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Cassia seed, obesity, Therapeutic effect assessment, clinical trial