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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Unknown status

CT.gov ID

NCT02504515

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

906

Enrollment

Location

Arms

Duration (Months)

28.3

Patients Per Site Per Month

Study Details

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	Phase
Anxiety Depression Premenstrual Tension Hot Flashes Muscular Diseases	Other: World Health Organization Quality of Life Bref Questionnaire	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

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

Quality of life [one year]

Secondary Outcome Measures

Quality of life [six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais	Brazil	30130-100

Sponsors and Collaborators

Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rubens Lene Carvalho Tavares, Professor, Federal University of Minas Gerais

ClinicalTrials.gov Identifier:

NCT02504515

Other Study ID Numbers:

22858113.9.0000.5149

First Posted:

Jul 22, 2015

Last Update Posted:

May 3, 2017

Last Verified:

May 1, 2017

Additional relevant MeSH terms:

Muscular Diseases

Hot Flashes

Premenstrual Syndrome

Study Results

No Results Posted as of May 3, 2017