NCT04252131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started May 2018

Typical duration for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

December 26, 2019

Last Update Submit

January 30, 2020

Conditions

Schizophrenia

Keywords

SchizophreniaCassia seedobesityTherapeutic effect assessmentclinical trial

Outcome Measures

Primary Outcomes (2)

  • 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

    12 weeks

  • sphygmomanometer

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

    12 weeks

Secondary Outcomes (2)

  • Blood analyzer

    12 weeks

  • Meridian energy skin conductivity assessment using amperometer (0-200uA)

    12 weeks

Study Arms (2)

Cassia seed

EXPERIMENTAL

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

Drug: cassia seed tablet

Cassia seed placebo

PLACEBO COMPARATOR

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

Interventions

cassia seed tabletDRUG

traditional Chinese herbs

Also known as: cassia obtusifolia
Cassia seedCassia seed placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calo Psychiatric Center

Pingtung City, Others, 925, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaObesity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • For-Wey Lung, MD, ScD

    Calo Psychiatric Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
All participants are randomized into treatment or placebo group. Investigator also did not know who are in which group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
superintendent

Study Record Dates

First Submitted

December 26, 2019

First Posted

February 5, 2020

Study Start

May 17, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

TW(1)