Treating Climacteric Symptoms With a Complex Homeopathic Remedy

This study has been completed.
Sponsor:
Collaborator:
Wala GmbH
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00152776
First received: September 8, 2005
Last updated: April 18, 2007
Last verified: April 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   45 Years and older
Genders 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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00152776     History of Changes
Other Study ID Numbers: HD04
Study First Received: September 8, 2005
Last Updated: April 18, 2007
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
menopausal symptoms
complementary medicine

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 29, 2014