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临床试验/NCT05299775
NCT05299775已完成不适用

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

Taipei City Hospital1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2018年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
quality of life score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 49 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

quality of life score

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Chung-Hua Hsu

Clinical professor

Taipei City Hospital

研究点 (1)

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