search
Back to results

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
Calo Psychiatric Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Hawthorn, TG/HDL ratio, dyslipidemia, schizophrenia, antipsychotics

Eligibility Criteria

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

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

    First Posted
    September 4, 2018
    Last Updated
    September 6, 2018
    Sponsor
    Calo Psychiatric Center
    search

    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

    We'll reach out to this number within 24 hrs