Treating Climacteric Symptoms With a Complex Homeopathic Remedy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.

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Detailed Description

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Complementary treatments for climacteric symptoms are used by many women although their efficacy and safety is mostly unproven.

The use of the complex homeopathic remedy Ovaria comp. for the relief of climacteric symptoms will be examined in this three-armed intervention trial and measured with the menopause rating scale II before and after each study phase of 12 weeks. Participants will receive the verum during two treatment phases of 12 weeks and the placebo during one treatment phase of 12 weeks in different sequences and are stratified for post- and perimenopausal status.

Conditions

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Menopause Anxiety Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group I

ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks

Group Type PLACEBO_COMPARATOR

ovaria comp 10 globuli 3 times per day 24 weeks

Intervention Type DRUG

order of intervention and placebo varies between Groups I-III

Group II

Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks

Group Type PLACEBO_COMPARATOR

ovaria comp 10 globuli 3 times per day 24 weeks

Intervention Type DRUG

order of intervention and placebo varies between Groups I-III

Group III

ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks

Group Type PLACEBO_COMPARATOR

ovaria comp 10 globuli 3 times per day 24 weeks

Intervention Type DRUG

order of intervention and placebo varies between Groups I-III

Interventions

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ovaria comp 10 globuli 3 times per day 24 weeks

order of intervention and placebo varies between Groups I-III

Intervention Type DRUG

Other Intervention Names

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placebo globuli 3 times per day 12 weeks

Eligibility Criteria

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Inclusion Criteria

* Climacteric symptoms\>=3 Points in Menopause Rating Scale (MRS) II
* Communication possible

Exclusion Criteria

* Hormone replacement therapy within 2 weeks prior to study inclusion
* Other complementary treatments 7 days before and during the study
* Climacteric symptoms caused by operation, chemotherapy or hormonal therapy of cancer
* Allergy to components of the remedy, especially bee poison

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes