Schizophrenia
Conditions
Keywords
Schizophrenia, Cassia seed, obesity, Therapeutic effect assessment, clinical trial
Brief summary
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
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.
Interventions
DRUGcassia seed tablet
traditional Chinese herbs
Sponsors
Calo Psychiatric Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
All participants are randomized into treatment or placebo group. Investigator also did not know who are in which group.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| physiological parameter for measuring Height and weight | 12 weeks | the parameter of BMI in kg/m\^2 for exploring the changes of body mass index (BMI) after cassia obtusifolia treatment |
| sphygmomanometer | 12 weeks | the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood analyzer | 12 weeks | the concentration of lipid profile, including total cholesterol, triglyceride, high denisty lipoprotein and low density lipoprotein after cassia obtusifolia treatment. |
| Meridian energy skin conductivity assessment using amperometer (0-200uA) | 12 weeks | the parameter of meridian energy after cassia obtusifolia treatment |
Countries
Taiwan
Outcome results
None listed