The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics

NCT ID: NCT03663465

Last Updated: 2018-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

case control study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
two groups of participants and investigator

Study Groups

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Hawthorn and SGAs

SGAs has a dose of 3-20 gm/day, Hawthorn at a dose of 3 gm/day for six months.

Group Type EXPERIMENTAL

Hawthorn

Intervention Type OTHER

Hawthorn tablet

SGAs

Intervention Type DRUG

SGAs tablet

Hawthorn

Hawthorn at a dose of 3 gm/day for six months.

Group Type ACTIVE_COMPARATOR

Hawthorn

Intervention Type OTHER

Hawthorn tablet

Interventions

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Hawthorn

Hawthorn tablet

Intervention Type OTHER

SGAs

SGAs tablet

Intervention Type DRUG

Other Intervention Names

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second-generation antipsychotics

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Calo Psychiatric Center

OTHER

Sponsor Role lead

Responsible Party

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For-Wey Lung

Superintendent and Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MAB101-109

Identifier Type: -

Identifier Source: org_study_id

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