Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Calo Psychiatric Center

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: cassia seed tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04252131

106-046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Cassia seed

Experimental group

Description:

oral administration of Cassia seed (3.0g), once/day for 12 weeks

Treatment:

Drug: cassia seed tablet

Cassia seed placebo

Placebo Comparator group

Description:

oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks

Treatment:

Drug: cassia seed tablet