Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Calo Psychiatric Center92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia

Interventions

cassia seed tabletDRUG

traditional Chinese herbs

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Calo Psychiatric Center

Pingtung City, Others, Taiwan

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

sphygmomanometer

the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment

Time frame: 12 weeks

Secondary Outcomes

Blood analyzer

the concentration of lipid profile, including total cholesterol, triglyceride, high denisty lipoprotein and low density lipoprotein after cassia obtusifolia treatment.

Time frame: 12 weeks

Meridian energy skin conductivity assessment using amperometer (0-200uA)

the parameter of meridian energy after cassia obtusifolia treatment

Time frame: 12 weeks

Data from ClinicalTrials.gov

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