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

NCT03663465 | Completed DMC

• 1 other identifier: MAB101-109
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Hawthorn; TG/HDL ratio; dyslipidemia; schizophrenia; antipsychotics

Outcome Measures

Primary Outcomes (1)

• lipid profiles

  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

Study Arms (2)

Hawthorn and SGAs

EXPERIMENTAL

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

Other: Hawthorn; Drug: SGAs

Hawthorn

ACTIVE COMPARATOR

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

Other: Hawthorn

Interventions

Hawthorn OTHER

Hawthorn tablet

Hawthorn; Hawthorn and SGAs

SGAs DRUG

SGAs tablet

Also known as: second-generation antipsychotics

Hawthorn and SGAs

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Calo Psychiatric Center: lead

MeSH Terms

Conditions

Schizophrenia; Dyslipidemias

Interventions

crataegus extract

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: two groups of participants and investigator
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Superintendent and Attending physician

Model Details: case control study

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 10, 2018
• Study Start: January 1, 2013
• Primary Completion: December 31, 2013
• Study Completion: July 31, 2014
• Last Updated: September 10, 2018

Record last verified: 2018-09