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| Name | Class |
|---|---|
| Wala GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Placebo Comparator | ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks |
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| Group II | Placebo Comparator | Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks |
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| Group III | Placebo Comparator | ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ovaria comp 10 globuli 3 times per day 24 weeks | Drug | order of intervention and placebo varies between Groups I-III |
|
| Measure | Description | Time Frame |
|---|---|---|
| Climacteric symptoms | sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Follow-up for another 12 weeks of treatment or after cross-over to the placebo group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia U von Hagens, MD | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Complementary and Integrative Medicine | Heidelberg | Baden-Wurttemberg | D-69115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22017387 | Result | 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 2011 Oct 23. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
sum score and subscales of the MRS II |
| 12+12 weeks |
| Follow-up for cross-over to placebo after 24 weeks of treatment | sum score and subscales of the MRS II | 12+12+12 weeks |
| Diurnal profile of cortisol level before and after treatment phases | cortisol (saliva: morning, noon, evening) | 12+12+12 weeks |
| 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 |