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NCT Number: NCT05299775

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)

Diagnostic Test

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

Primary outcomes

  1. quality of life score

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2022
Registry last updated
Mar 29, 2022

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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