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Completed

NCT Number: NCT03663465

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

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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Hawthorn

Other

Hawthorn tablet

SGAs

Drug

SGAs tablet

Other names: second-generation antipsychotics

Primary outcomes

  1. lipid profiles

    Time frame: three days

    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.

Sponsors and collaborators

Lead sponsor

Calo Psychiatric Center

Other

Registry information

Official study title

The Disparity of Hawthorn Effects to Triglyceride/High-density Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Sep 10, 2018
Registry last updated
Sep 10, 2018

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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