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

Sponsor
Taipei City Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05299775
Collaborator
(none)
203
1
9.6
21.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)

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 Design

Study Type:
Observational
Actual Enrollment :
203 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men
Actual Study Start Date :
Sep 21, 2018
Actual Primary Completion Date :
Feb 18, 2019
Actual Study Completion Date :
Jul 9, 2019

Arms and Interventions

Arm Intervention/Treatment
HIV infected time

Group are divided by Infected time: 0-2W, 2W-12M, >1Y

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.
Other Names:
  • Wang Qi nine kinds of TCM constitution Questionnaire
  • different constitutions

    Group are divided by different constitutions:It includes 9 basic types of constitution, yang deficiency , yin deficiency , qi deficiency , phlegm dampness , damp-heat, blood stasis, special diathesis , qi depression , gentleness constitution .

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 49 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei City Hospital Taipei Taiwan 10845

    Sponsors and Collaborators

    • Taipei City Hospital

    Investigators

    • Study Director: Chung-Hua Hsu, clinical professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chung-Hua Hsu, Clinical professor, Taipei City Hospital
    ClinicalTrials.gov Identifier:
    NCT05299775
    Other Study ID Numbers:
    • TCHIRB-10707110
    First Posted:
    Mar 29, 2022
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 29, 2022