Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men

HIV Infections Clinical Trial

Official title:

Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299775
• Other study ID #: TCHIRB-10707110
• Status: Completed
• Start date: September 21, 2018
• Est. completion date: July 9, 2019

Study information

• Verified date: March 2022
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study explores the pathological constitution as it relates to low quality of life with HIV- infected MSM patients, as a reference for clinical treatment.

Description:

Introduction :This study explores the pathological constitution as it relates to low quality of life with HIV- infected MSM patients, as a reference for clinical treatment. Methods :It has a cross-sectional research design using structured questionnaires to collect data,including patient's basic case data, CD4+, CD4+/CD8+ ratio, Wang Qi constitution and WHOQOL-BREF -Taiwan version questionnaires. We consider the association between the constitutions and quality of life for HIV-infected MSM patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 9, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 49 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with HIV infected.
• Age greater than 20 years old (including) and less than 60 years old.
• Conscious clear and voluntary to attend the project with agreement.
• Willing to fill out the informed consent form.

Exclusion Criteria:

• conscious unclear
• Patients had histories of severe psychiatric disorders ( ex: schizophrenia) or if they met the criteria of Diagnostic and Statistical Manual of Mental Disorders ( ex: dementia)
• Age < 20 years old.
• The patient does not want to fill out the informed consent form for any reason.

Related Conditions & MeSH terms

• HIV Infections
• Quality of Life

Intervention

Diagnostic Test:
• World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)
WHOQOL-BREF-Taiwan version is used to measure the quality of life in HIV infected. Wang Qi nine kinds of TCM constitution Questionnaire is used to measure the constitution of HIV infected.

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life score	investigate different quality of life score of HIV infected time in the physical,psychological, social, and environmental domains.; Outcome Measure:4 quality of life scores for each constitution , In the WHOQOL-BREF Taiwan item scores range from 1 (worst condition) to 5 (best condition), except for 3 items (Ph1, Ph2, and Ps6), which have reverse scores. Two scales (0-100 and 4-20, with a higher score indicating better QOL) can be transformed into domain scores for each domain and we used the 4-20 scale in this study,Add the item scores for each domain ,the higher scores indicating better quality of life	Lasts for 1 year
Primary	TCM constitution	Investigate TCM constitution composed of HIV-infected in yang deficiency , yin deficiency , qi deficiency , phlegm dampness , damp-heat , blood stasis , special diathesis , qi stagnation , and gentleness constitution .; Outcome Measure:Nine kinds TCM constitution-the constitution type must be judged according to the standards. Original score = sum of the scores of items for each constitution, and then the original score is converted into a conversion score [conversion score = [(original score-number of answer items) / answer items × 4] × 100.; Judgment of constitutions: gentleness is a normal constitution, and others are pathological constitutions. Gentleness constitution conversion score = 60 points, and other pathological constitution conversion score <30 points, it is Gentleness constitution; pathological constitution conversion score = 40 is considered pathological constitution, The higher the conversion score is the more obvious the constitution trend	Lasts for 1 year