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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02504515
• Other study ID #: 22858113.9.0000.5149
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2015
• Last updated: May 2, 2017
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Federal University of Minas Gerais
• Contact: Rubens Tavares, MD, PhD
• Phone: +5531 3409 9485
• Email: rubens.ufmg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 906
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Hot Flashes
• Muscular Diseases
• Premenstrual Syndrome
• Premenstrual Tension

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (2)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		one year
Secondary	Quality of life		six months