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

Completed

• Conditions: HIV Infections; Quality of Life

• Registration Number: NCT05299775
• Lead Sponsor: Taipei City Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-09-21
• Primary Completion: 2019-02-18
• Study Completion: 2019-07-09
• Study First Submitted: 2021-12-08
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-24
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 203

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of life score	Lasts for 1 year	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
TCM constitution	Lasts for 1 year	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

Trial Locations

Locations (1)

Taipei City Hospital; 🇨🇳 Taipei, Taiwan