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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663465
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
For-Wey Lung, Calo Psychiatric Center

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: Hawthorn Drug: SGAs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: case control study
Masking: Double (Participant, Investigator)
Masking Description: two groups of participants and investigator
Primary Purpose: Prevention
Official Title: The Disparity of Hawthorn Effects to Triglyceride/High-density Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : July 31, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hawthorn and SGAs
SGAs has a dose of 3-20 gm/day, Hawthorn at a dose of 3 gm/day for six months.
Other: Hawthorn
Hawthorn tablet

Drug: SGAs
SGAs tablet
Other Name: second-generation antipsychotics

Active Comparator: Hawthorn
Hawthorn at a dose of 3 gm/day for six months.
Other: Hawthorn
Hawthorn tablet




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: For-Wey Lung, Superintendent and Attending physician, Calo Psychiatric Center
ClinicalTrials.gov Identifier: NCT03663465    
Other Study ID Numbers: MAB101-109
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by For-Wey Lung, Calo Psychiatric Center:
Hawthorn
TG/HDL ratio
dyslipidemia
schizophrenia
antipsychotics
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs