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Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life

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ClinicalTrials.gov Identifier: NCT02504515
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Rubens Lene Carvalho Tavares, Federal University of Minas Gerais

July 20, 2015
July 22, 2015
May 3, 2017
April 2015
December 2017   (Final data collection date for primary outcome measure)
Quality of life [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT02504515 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: six months ]
Same as current
Not Provided
Not Provided
 
Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life
Evaluating Treatment With Homeopathy, Acupuncture, and Anthroposophic Medicine in Improving the Quality of Life for Women Treated at the Public Unified Healthcare System
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).
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Anxiety
  • Depression
  • Premenstrual Tension
  • Hot Flashes
  • Muscular Diseases
Other: World Health Organization Quality of Life Bref Questionnaire

The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months.

The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.

  • Active Comparator: Homeopathy
    Intervention: Other: World Health Organization Quality of Life Bref Questionnaire
  • Active Comparator: Allopathy homeopathy control
    Intervention: Other: World Health Organization Quality of Life Bref Questionnaire
  • Active Comparator: Acupuncture
    Intervention: Other: World Health Organization Quality of Life Bref Questionnaire
  • Active Comparator: Allopathy acupuncture control
    Intervention: Other: World Health Organization Quality of Life Bref Questionnaire
  • Active Comparator: Anthroposophic medicine
    Intervention: Other: World Health Organization Quality of Life Bref Questionnaire
  • Active Comparator: Allopathy anthroposophy control
    Intervention: Other: World Health Organization Quality of Life Bref Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
906
Same as current
December 2017
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Rubens Tavares, MD, PhD +5531 3409 9485 rubens.ufmg@gmail.com
Brazil
 
 
NCT02504515
22858113.9.0000.5149
Yes
Not Provided
Not Provided
Rubens Lene Carvalho Tavares, Federal University of Minas Gerais
Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Not Provided
Federal University of Minas Gerais
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP