跳至主要内容
临床试验/NCT02504515
NCT02504515Unknown不适用

Evaluating Treatment With Homeopathy, Acupuncture, and Anthroposophic Medicine in Improving the Quality of Life for Women Treated at the Public Unified Healthcare System

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 906 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
906
试验地点
1
主要终点
Quality of life

研究概览

简要总结

Patients will be randomly assigned to two separate groups. Both patient groups will be evaluated using the WHOQOL-BREF questionaire. Evaluations will be carried out just before the study begins and at intervals of six months during a period of one year for a total of three evaluations. Group one will be made up of patients who will begin homeopathy or acupuncture or anthroposophic medicine treatment and patients from group two will start homeopathy or acupuncture or anthroposophic medicine six months after the beginning of the study. Each one of these three research branches will be done independently (Homeopathy versus control; Acupuncture versus control; Anthroposophic Medicine versus control). Conventional medical treatment will be available for all patients in both groups. A data sheet will be filled out on each patient with data as to age, education level, marital status and the patient's own perception of their health status. During the interviews the interviewer will have no influence whatsoever over the respondents' answers. Integrative/complementary or traditional medicine doctors do not participate in the research and will not be informed about which patients are participating in this project, and as such the research will be blinded for these doctors. Minitab software, version 16, was used for sample calculation through the module Power and Sample Size. Sample calculation option for paired t-tests before and after intervention demonstrated the need to randomize 906 patients: 450 patients for homeopathy branch (225 patients in the homeopathy group and 225 patients in the control group), 228 patients for acupuncture branch (114 patients in the acupuncture group and 114 patients in the control group), and 228 patients for anthroposophic medicine branch (114 patients in the anthroposophic medicine group and 114 patients in the control group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women over 18 years of age
  • •Patients with chronic diseases

排除标准

  • •Women below 18 years of age
  • •Previous treatment with homeopathy (for homeopathy versus control branch)
  • •Previous treatment with acupuncture (for acupuncture versus control branch)
  • •Previous treatment with anthroposophic medicine (for anthroposophic medicine versus control branch)

研究组 & 干预措施

Homeopathy

Active Comparator

干预措施: World Health Organization Quality of Life Bref Questionnaire (Other)

Allopathy homeopathy control

Active Comparator

干预措施: World Health Organization Quality of Life Bref Questionnaire (Other)

Acupuncture

Active Comparator

干预措施: World Health Organization Quality of Life Bref Questionnaire (Other)

Allopathy acupuncture control

Active Comparator

干预措施: World Health Organization Quality of Life Bref Questionnaire (Other)

Anthroposophic medicine

Active Comparator

干预措施: World Health Organization Quality of Life Bref Questionnaire (Other)

Allopathy anthroposophy control

Active Comparator

干预措施: World Health Organization Quality of Life Bref Questionnaire (Other)

结局指标

主要结局

Quality of life

时间窗: one year

次要结局

  • Quality of life(six months)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rubens Lene Carvalho Tavares

Professor

Federal University of Minas Gerais

研究点 (1)

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