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NCT Number: NCT04252131

Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

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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Key information

Conditions

Schizophrenia Body Weight Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Calo Psychiatric Center

Pingtung City, Others, 925, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cassia seed tablet

Drug

traditional Chinese herbs

Other names: cassia obtusifolia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Calo Psychiatric Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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