AnxietyNCT02504515
Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life
A study testing World Health Organization Quality of Life Bref Questionnaire in people with Anxiety and Depression, run by Federal University of Minas Gerais at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Depression, Premenstrual Tension
- What is being tested?
- World Health Organization Quality of Life Bref Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 906 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years of age
- Patients with chronic diseases
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
Rubens Tavares, MD,PhD, +5531 3409 9485, rubens.ufmg@gmail.com
Cybelle Costa, MD, +5531 3409 9485, cmvcosta@yahoo.com.br
About this study
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
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).
- Conditions
- Anxiety, Depression, Premenstrual Tension, Hot Flashes, Muscular Diseases
- Being tested
- World Health Organization Quality of Life Bref Questionnaire
- Medical subject headings
- Anxiety Disorders, Depression, Premenstrual Syndrome, Hot Flashes, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
World Health Organization Quality of Life Bref QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Homeopathy | Active comparator | Not described Receives: Other: World Health Organization Quality of Life Bref Questionnaire |
| Allopathy homeopathy control | Active comparator | Not described Receives: Other: World Health Organization Quality of Life Bref Questionnaire |
| Acupuncture | Active comparator | Not described Receives: Other: World Health Organization Quality of Life Bref Questionnaire |
| Allopathy acupuncture control | Active comparator | Not described Receives: Other: World Health Organization Quality of Life Bref Questionnaire |
| Anthroposophic medicine | Active comparator | Not described Receives: Other: World Health Organization Quality of Life Bref Questionnaire |
| Allopathy anthroposophy control | Active comparator | Not described Receives: Other: World Health Organization Quality of Life Bref Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: one year
Secondary outcomes (1)
Quality of life
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 906 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Rubens Lene Carvalho Tavares, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504515
- Sponsor's protocol ID
- 22858113.9.0000.5149
- Status last verified
- May 2017
- First submitted
- 20 Jul 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02504515
- Acronym / sponsor ID
- 22858113.9.0000.5149
- Conditions
- Anxiety, Depression, Premenstrual Tension, Hot Flashes, Muscular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 906 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Homeopathy | Active comparator | Other: World Health Organization Quality of Life Bref Questionnaire |
| Allopathy homeopathy control | Active comparator | Other: World Health Organization Quality of Life Bref Questionnaire |
| Acupuncture | Active comparator | Other: World Health Organization Quality of Life Bref Questionnaire |
| Allopathy acupuncture control | Active comparator | Other: World Health Organization Quality of Life Bref Questionnaire |
| Anthroposophic medicine | Active comparator | Other: World Health Organization Quality of Life Bref Questionnaire |
| Allopathy anthroposophy control | Active comparator | Other: World Health Organization Quality of Life Bref Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women over 18 years of age
- Patients with chronic diseases
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| World Health Organization Quality of Life Bref QuestionnaireThe 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. | Other | Acupuncture, Allopathy acupuncture control, Allopathy anthroposophy control, Allopathy homeopathy control, Anthroposophic medicine, Homeopathy |
Primary outcome
Quality of life
Time frame: one year
1 secondary outcome
Quality of life
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing World Health Organization Quality of Life Bref Questionnaire in people with Anxiety and Depression, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens Tavares, MD, PhD (+5531 3409 9485, rubens.ufmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.