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

May 2, 2017 updated by: Rubens Lene Carvalho Tavares, Federal University of Minas Gerais

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

906

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Recruiting
        • Federal University of Minas Gerais
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupuncture
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
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: Allopathy homeopathy control
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: Allopathy acupuncture control
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: Anthroposophic medicine
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: Allopathy anthroposophy control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22858113.9.0000.5149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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