The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hawthorn
SGAs
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Hawthorn, TG/HDL ratio, dyslipidemia, schizophrenia, antipsychotics
Eligibility Criteria
Inclusion Criteria:
- Patients in case group who had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- All participants in the case group had previously received antipsychotic treatment for a period of time.
Exclusion Criteria:
- Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample
- Participants were pregnant and lactating women in both group, were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hawthorn and SGAs
Hawthorn
Arm Description
SGAs has a dose of 3-20 gm/day, Hawthorn at a dose of 3 gm/day for six months.
Hawthorn at a dose of 3 gm/day for six months.
Outcomes
Primary Outcome Measures
lipid profiles
lipid profiles (including TC, TG, HDL, LDL) were collected three times (at first week, 12th week and 24th week. Total collecting day were three days.
Secondary Outcome Measures
Full Information
NCT ID
NCT03663465
First Posted
September 4, 2018
Last Updated
September 6, 2018
Sponsor
Calo Psychiatric Center
1. Study Identification
Unique Protocol Identification Number
NCT03663465
Brief Title
The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
Official Title
The Disparity of Hawthorn Effects to Triglyceride/High-density Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
July 31, 2014 (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
Yes
5. Study Description
Brief Summary
Importance: The problems of side effects of metabolic disturbances in schizophrenic patients have been of worldwide concern for some time. Patients with dyslipidemia have an increased risk of cardiovascular diseases. A Chinese herb, Hawthorn, is widely used for the treatment of dyslipidemia.
Objective: Therefore, this study aimed to investigate the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics.
Design, Setting, and Participants: A longitudinal case-control study was used in a general hospital in Taiwan. A total of 59 schizophrenics treated with antipsychotics, and 76 healthy adult subjects, who were all hospital workers, were enrolled in this study.
Main outcomes and measures: All participants received Hawthorn at a dose of 3 gm/day for six months.
Detailed Description
The problem of metabolic disturbances in schizophrenic patients who take antipsychotics has always been a cause for global concern and discussion. Although Hawthorn is widely used in the treatment of heart problems and the lowering of blood lipid levels, it is unknown whether Hawthorn has an effect in schizophrenic patients treated with antipsychotics. Hence, there are several areas of interest in the present study: 1) the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics; 2) a comparison of lipid profile levels between schizophrenic patients and healthy adults; 3) the contributing factors that relate to changes in lipid profile levels in patients who take Hawthorn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Hawthorn, TG/HDL ratio, dyslipidemia, schizophrenia, antipsychotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
case control study
Masking
ParticipantInvestigator
Masking Description
two groups of participants and investigator
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hawthorn and SGAs
Arm Type
Experimental
Arm Description
SGAs has a dose of 3-20 gm/day, Hawthorn at a dose of 3 gm/day for six months.
Arm Title
Hawthorn
Arm Type
Active Comparator
Arm Description
Hawthorn at a dose of 3 gm/day for six months.
Intervention Type
Other
Intervention Name(s)
Hawthorn
Intervention Description
Hawthorn tablet
Intervention Type
Drug
Intervention Name(s)
SGAs
Other Intervention Name(s)
second-generation antipsychotics
Intervention Description
SGAs tablet
Primary Outcome Measure Information:
Title
lipid profiles
Description
lipid profiles (including TC, TG, HDL, LDL) were collected three times (at first week, 12th week and 24th week. Total collecting day were three days.
Time Frame
three days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients in case group who had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
All participants in the case group had previously received antipsychotic treatment for a period of time.
Exclusion Criteria:
Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample
Participants were pregnant and lactating women in both group, were excluded.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
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