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Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
cassia seed tablet
Sponsored by
Calo Psychiatric Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cassia seed, obesity, Therapeutic effect assessment, clinical trial

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Calo Psychiatric Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cassia seed

Cassia seed placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
sphygmomanometer
the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment

Secondary Outcome Measures

Blood analyzer
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)
the parameter of meridian energy after cassia obtusifolia treatment

Full Information

First Posted
December 26, 2019
Last Updated
January 30, 2020
Sponsor
Calo Psychiatric Center
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1. Study Identification

Unique Protocol Identification Number
NCT04252131
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Calo Psychiatric Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cassia seed, obesity, Therapeutic effect assessment, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
All participants are randomized into treatment or placebo group. Investigator also did not know who are in which group.
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cassia seed
Arm Type
Experimental
Arm Description
oral administration of Cassia seed (3.0g), once/day for 12 weeks
Arm Title
Cassia seed placebo
Arm Type
Placebo Comparator
Arm Description
oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
cassia seed tablet
Other Intervention Name(s)
cassia obtusifolia
Intervention Description
traditional Chinese herbs
Primary Outcome Measure Information:
Title
physiological parameter for measuring Height and weight
Description
the parameter of BMI in kg/m^2 for exploring the changes of body mass index (BMI) after cassia obtusifolia treatment
Time Frame
12 weeks
Title
sphygmomanometer
Description
the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Blood analyzer
Description
the concentration of lipid profile, including total cholesterol, triglyceride, high denisty lipoprotein and low density lipoprotein after cassia obtusifolia treatment.
Time Frame
12 weeks
Title
Meridian energy skin conductivity assessment using amperometer (0-200uA)
Description
the parameter of meridian energy after cassia obtusifolia treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
For-Wey Lung, MD, ScD
Organizational Affiliation
Calo Psychiatric Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calo Psychiatric Center
City
Pingtung
State/Province
Others
ZIP/Postal Code
925
Country
Taiwan

12. IPD Sharing Statement

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Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

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