Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2019-10-31

Brief Summary

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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.

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Schizophrenia Schizoaffective Disorder

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

All participants are randomized into treatment or placebo group. Investigator also did not know who are in which group.

Study Groups

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Cassia seed

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

Group Type EXPERIMENTAL

cassia seed tablet

Intervention Type DRUG

traditional Chinese herbs

Cassia seed placebo

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

Group Type PLACEBO_COMPARATOR

cassia seed tablet

Intervention Type DRUG

traditional Chinese herbs

Interventions

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cassia seed tablet

traditional Chinese herbs

Intervention Type DRUG

Other Intervention Names

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cassia obtusifolia

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes