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Treating Climacteric Symptoms With a Complex Homeopathic Remedy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152776
First Posted: September 9, 2005
Last Update Posted: April 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wala GmbH
Information provided by:
Heidelberg University
  Purpose
The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.

Condition Intervention Phase
Menopause Anxiety Disorders Depression Drug: ovaria comp 10 globuli 3 times per day Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Climacteric symptoms measured as the difference of the sum score of the menopause rating scale before and after 12 weeks of treatment

Secondary Outcome Measures:
  • Climacteric symptoms measured as the difference of the subscales of the menopause rating scale before and after 12 weeks of treatment
  • Follow-up for another 12 weeks of treatment or after cross-over to the placebo group
  • Follow-up for cross-over to placebo after 24 weeks of treatment
  • Diurnal profile of cortisol level before and after treatment phases
  • Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period

Estimated Enrollment: 102
Study Start Date: February 2005
Study Completion Date: December 2006
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152776


Locations
Germany
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Württemberg, Germany, D-69115
Sponsors and Collaborators
Heidelberg University
Wala GmbH
Investigators
Principal Investigator: Cornelia U von Hagens, MD Heidelberg University
  More Information

ClinicalTrials.gov Identifier: NCT00152776     History of Changes
Other Study ID Numbers: HD04
First Submitted: September 8, 2005
First Posted: September 9, 2005
Last Update Posted: April 19, 2007
Last Verified: April 2007

Keywords provided by Heidelberg University:
menopausal symptoms
complementary medicine

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders


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