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临床试验/NCT03663465
NCT03663465已完成不适用

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

Calo Psychiatric Center0 个研究点目标入组 135 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
主要终点
lipid profiles

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

two groups of participants and investigator

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Hawthorn and SGAs

Experimental

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

干预措施: Hawthorn (Other)

Hawthorn and SGAs

Experimental

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

干预措施: SGAs (Drug)

Hawthorn

Active Comparator

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

干预措施: Hawthorn (Other)

结局指标

主要结局

lipid profiles

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Calo Psychiatric Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

For-Wey Lung

Superintendent and Attending physician

Calo Psychiatric Center

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