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Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252131
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
For-Wey Lung, Calo Psychiatric Center

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: cassia seed tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description: All participants are randomized into treatment or placebo group. Investigator also did not know who are in which group.
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Cassia

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 Name: 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 Name: cassia obtusifolia




Primary Outcome Measures :
  1. 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

  2. sphygmomanometer [ Time Frame: 12 weeks ]
    the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment


Secondary Outcome Measures :
  1. 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.

  2. Meridian energy skin conductivity assessment using amperometer (0-200uA) [ Time Frame: 12 weeks ]
    the parameter of meridian energy after cassia obtusifolia treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252131


Locations
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Taiwan
Calo Psychiatric Center
Pingtung, Others, Taiwan, 925
Sponsors and Collaborators
Calo Psychiatric Center
Investigators
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Principal Investigator: For-Wey Lung, MD, ScD Calo Psychiatric Center
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Responsible Party: For-Wey Lung, superintendent, Calo Psychiatric Center
ClinicalTrials.gov Identifier: NCT04252131    
Other Study ID Numbers: 106-046
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by For-Wey Lung, Calo Psychiatric Center:
Schizophrenia
Cassia seed
obesity
Therapeutic effect assessment
clinical trial
Additional relevant MeSH terms:
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Obesity
Schizophrenia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders