Treating Climacteric Symptoms With a Complex Homeopathic Remedy
The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.
Drug: ovaria comp 10 globuli 3 times per day
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study|
- Climacteric symptoms measured as the difference of the sum score of the menopause rating scale before and after 12 weeks of treatment
- 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
|Study Start Date:||February 2005|
|Study Completion Date:||December 2006|
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.
|Department of Complementary and Integrative Medicine|
|Heidelberg, Baden-Württemberg, Germany, D-69115|
|Principal Investigator:||Cornelia U von Hagens, MD||Heidelberg University|