Clinical trial NCT04252131: Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
Official title: Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
Cassia seed
obesity
Therapeutic effect assessment
clinical trial
Lead sponsor: Calo Psychiatric Center
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 92
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: physiological parameter for measuring Height and weight
timeFrame: 12 weeks
measure: sphygmomanometer
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood analyzer
timeFrame: 12 weeks
measure: Meridian energy skin conductivity assessment using amperometer (0-200uA)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: Calo Psychiatric Center
state: Others
Study officials:
affiliation: Calo Psychiatric Center
name: For-Wey Lung, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References: