Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: cassia seed tablet

• Registration Number: NCT04252131
• Lead Sponsor: Calo Psychiatric Center

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.

Study Timeline

• Study Start: 2018-05-17
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Study First Submitted: 2019-12-26
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Calo Psychiatric Center; 🇨🇳 Pingtung, Others, Taiwan