Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252131
• Other study ID #: 106-046
• Status: Completed
• Phase: Phase 1
• Start date: May 17, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: January 2020
• Source: Calo Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Schizophrenia

Intervention

Drug:
• cassia seed tablet
traditional Chinese herbs

Locations

Country	Name	City	State
Taiwan	Calo Psychiatric Center	Pingtung	Others

Sponsors (1)

Lead Sponsor	Collaborator
Calo Psychiatric Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	sphygmomanometer	the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment	12 weeks
Secondary	Blood analyzer	the concentration of lipid profile, including total cholesterol, triglyceride, high denisty lipoprotein and low density lipoprotein after cassia obtusifolia treatment.	12 weeks
Secondary	Meridian energy skin conductivity assessment using amperometer (0-200uA)	the parameter of meridian energy after cassia obtusifolia treatment	12 weeks