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

Sociedade Hospital Samaritano

Status and phase: Unknown; Phase 4

Conditions: Climacteric

Treatments: Drug: Hormones; Other: flower therapy; Other: therapeutic touch; Other: auricular therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00617500

SHS 18/07

Details and patient eligibility

About

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.

Enrollment: 278 estimated patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 4 patient groups

Hormone

Active Comparator group

Treatment:

Drug: Hormones

flower therapy

Experimental group

Treatment:

Other: flower therapy

therapeutic touch

Experimental group

Treatment:

Other: therapeutic touch

auriculotherapy

Experimental group

Treatment:

Other: auricular therapy