Treating Climacteric Symptoms With a Complex Homeopathic Remedy

Depression Clinical Trial

Official title:

Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152776
• Other study ID #: HD04
• Status: Completed
• Phase: Phase 4
• Start date: February 2005
• Est. completion date: December 2006

Study information

• Verified date: June 2018
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Menopause

Intervention

Drug:
• ovaria comp 10 globuli 3 times per day 24 weeks
order of intervention and placebo varies between Groups I-III

Locations

Country	Name	City	State
Germany	Department of Complementary and Integrative Medicine	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Wala GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

von Hagens C, Schiller P, Godbillon B, Osburg J, Klose C, Limprecht R, Strowitzki T. Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial. Climacteric. 2012 Aug;15(4):358-67. doi: 10.3109/13697137.2011.597895. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Climacteric symptoms	sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment	12 weeks
Secondary	Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II)	difference of the subscales of the menopause rating scale before and after 12 weeks of treatment	12 weeks
Secondary	Follow-up for another 12 weeks of treatment or after cross-over to the placebo group	sum score and subscales of the MRS II	12+12 weeks
Secondary	Follow-up for cross-over to placebo after 24 weeks of treatment	sum score and subscales of the MRS II	12+12+12 weeks
Secondary	Diurnal profile of cortisol level before and after treatment phases	cortisol (saliva: morning, noon, evening)	12+12+12 weeks
Secondary	Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period	Hospital Anxiety and Depression Scale	12+12+12 weeks