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

September 8, 2005
April 18, 2007
February 2005
Not Provided
Climacteric symptoms measured as the difference of the sum score of the menopause rating scale before and after 12 weeks of treatment
Same as current
Complete list of historical versions of study NCT00152776 on ClinicalTrials.gov Archive Site
  • 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
  • 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 HADS-D before and after treatment period
Not Provided
Not Provided
 
Treating Climacteric Symptoms With a Complex Homeopathic Remedy
Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Menopause
  • Anxiety Disorders
  • Depression
Drug: ovaria comp 10 globuli 3 times per day
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
December 2006
Not Provided

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
Female
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00152776
HD04
No
Not Provided
Heidelberg University
Wala GmbH
Principal Investigator: Cornelia U von Hagens, MD Heidelberg University
Heidelberg University
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP