Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life
Primary Purpose
Anxiety, Depression, Premenstrual Tension
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
World Health Organization Quality of Life Bref Questionnaire
Sponsored by
About this trial
This is an interventional health services research trial for Anxiety
Eligibility 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)
Sites / Locations
- Federal University of Minas GeraisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Homeopathy
Allopathy homeopathy control
Acupuncture
Allopathy acupuncture control
Anthroposophic medicine
Allopathy anthroposophy control
Arm Description
Outcomes
Primary Outcome Measures
Quality of life
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT02504515
First Posted
July 20, 2015
Last Updated
May 2, 2017
Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02504515
Brief Title
Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Premenstrual Tension, Hot Flashes, Muscular Diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
906 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Homeopathy
Arm Type
Active Comparator
Arm Title
Allopathy homeopathy control
Arm Type
Active Comparator
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Title
Allopathy acupuncture control
Arm Type
Active Comparator
Arm Title
Anthroposophic medicine
Arm Type
Active Comparator
Arm Title
Allopathy anthroposophy control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
World Health Organization Quality of Life Bref Questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
one year
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens Tavares, MD, PhD
Phone
+5531 3409 9485
Email
rubens.ufmg@gmail.com
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubens Tavares, MD,PhD
Phone
+5531 3409 9485
Email
rubens.ufmg@gmail.com
First Name & Middle Initial & Last Name & Degree
Cybelle Costa, MD
Phone
+5531 3409 9485
Email
cmvcosta@yahoo.com.br
12. IPD Sharing Statement
Learn more about this trial
Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life
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