Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

January 30, 2020 updated by: For-Wey Lung, Calo Psychiatric Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Others
      • Pingtung, Others, Taiwan, 925
        • Calo Psychiatric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cassia seed
oral administration of Cassia seed (3.0g), once/day for 12 weeks
Drug: cassia seed tablet
traditional Chinese herbs
Other Names:
  • cassia obtusifolia
PLACEBO_COMPARATOR: Cassia seed placebo
oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks
Drug: cassia seed tablet
traditional Chinese herbs
Other Names:
  • cassia obtusifolia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physiological parameter for measuring Height and weight
Time Frame: 12 weeks
the parameter of BMI in kg/m^2 for exploring the changes of body mass index (BMI) after cassia obtusifolia treatment
12 weeks
sphygmomanometer
Time Frame: 12 weeks
the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood analyzer
Time Frame: 12 weeks
the concentration of lipid profile, including total cholesterol, triglyceride, high denisty lipoprotein and low density lipoprotein after cassia obtusifolia treatment.
12 weeks
Meridian energy skin conductivity assessment using amperometer (0-200uA)
Time Frame: 12 weeks
the parameter of meridian energy after cassia obtusifolia treatment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calo Psychiatric Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 17, 2018

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

December 26, 2019

First Submitted That Met QC Criteria

January 30, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106-046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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