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

September 6, 2018 updated by: For-Wey Lung, Calo Psychiatric Center

The Disparity of Hawthorn Effects to Triglyceride/High-density 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • second-generation antipsychotics
Active Comparator: Hawthorn
Hawthorn at a dose of 3 gm/day for six months.
Other: Hawthorn
Hawthorn tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calo Psychiatric Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

July 31, 2014

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAB101-109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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