Trial record 11 of 58 for:    (complementary OR alternative) medicine AND menopause

Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Sociedade Hospital Samaritano.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by:
Sociedade Hospital Samaritano
ClinicalTrials.gov Identifier:
NCT00617500
First received: January 23, 2008
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

The alternative and complementary therapies are being gradually included in the Brazilian Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and Complementary Practices in Brazil . However, though this thematic is also included in the National Agenda of Research Priorities concerning Health, published studies concerning this matter are quite scarce. The World Health Organization (WHO) indicated that it is a big challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency and the quality of such practices. WHO also pointed out the clinical situations where they could be applied and that is why this investigation we are undertaken is fully justified.

Annoying signs and symptoms which come along with the climacteric period, especially anxiety, insomnia and hot flushes, change women´s life quality and their affective, social and business relationships as well. Consequently, this can generate sadness, depression and isolation.

Many women cannot undergo hormonal replacement, for several reasons: or they have some illnesses which reject hormones, or due to hypersensitiveness reactions or even economical difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal replacement and complementary therapies which compose this study are not known yet .

The complementary therapies proposed in this study concern non-invasive methods, of low cost, which justify being researched in order to verify the potential of those annoying signs alleviation.


Condition Intervention Phase
Climacteric
Other: flower therapy
Other: therapeutic touch
Other: auricular therapy
Drug: Hormones
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Resource links provided by NLM:


Further study details as provided by Sociedade Hospital Samaritano:

Primary Outcome Measures:
  • annoying signs and climacteric symptoms [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 278
Study Start Date: July 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hormone Drug: Hormones
Estradiol 1 mg and a drospirenone 2mg/day (3 months)
Experimental: flower therapy Other: flower therapy
Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
Experimental: therapeutic touch Other: therapeutic touch
Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
Experimental: auriculotherapy Other: auricular therapy
Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.

  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Recruited and registered in local of the study
  • They should present the signs and symptoms checked - insomnia, anxiety and hot flushes, they felt at the beginning of the climacteric
  • They should not be under hormonal replacement or even should have stopped their use more than 90 days

Exclusion criteria:

  • women who undergo a hysterectomy surgery
  • women using hormonal therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617500

Locations
Brazil
Hospital Samaritano
São Paulo, Brazil, 01232-010
Nursing School of University of São Paulo
São Paulo, Brazil, 01232-010
Sponsors and Collaborators
Sociedade Hospital Samaritano
University of Sao Paulo
Investigators
Study Director: Eliseth R Leão, PhD Hospital Samaritano
Study Director: Maria Julia P Silva, PhD University of São Paulo
Principal Investigator: Léia Sales, MscN University of São Paulo
Principal Investigator: Ivaldo da Silva, PhD Tocogynecological Department of São Paulo Federal University
Principal Investigator: Maria C Martinez, PhD Hospital Samaritano
  More Information

No publications provided

Responsible Party: Eliseth Ribeiro Leão, Scientific Research Department of Samaritano Hospital
ClinicalTrials.gov Identifier: NCT00617500     History of Changes
Other Study ID Numbers: SHS 18/07
Study First Received: January 23, 2008
Last Updated: September 18, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Sociedade Hospital Samaritano:
climacteric
complementary therapy
hormonal replacement therapy

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014