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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:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Anxiety Depression Premenstrual Tension Hot Flashes Muscular Diseases Other: World Health Organization Quality of Life Bref Questionnaire

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 906 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating Treatment With Homeopathy, Acupuncture, and Anthroposophic Medicine in Improving the Quality of Life for Women Treated at the Public Unified Healthcare System
Study Start Date : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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: 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: 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.



Outcome Measures

Primary Outcome Measures :
  1. Quality of life [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: six months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504515


Contacts
Contact: Rubens Tavares, MD, PhD +5531 3409 9485 rubens.ufmg@gmail.com

Locations
Brazil
Federal University of Minas Gerais Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Contact: Rubens Tavares, MD,PhD    +5531 3409 9485    rubens.ufmg@gmail.com   
Contact: Cybelle Costa, MD    +5531 3409 9485    cmvcosta@yahoo.com.br   
Sponsors and Collaborators
Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
More Information

Responsible Party: Rubens Lene Carvalho Tavares, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02504515     History of Changes
Other Study ID Numbers: 22858113.9.0000.5149
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Hot Flashes
Muscular Diseases
Premenstrual Syndrome
Signs and Symptoms
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Menstruation Disturbances
Pathologic Processes