Anxiety Disorders, Depression, Menopause
Conditions
Keywords
menopausal symptoms, complementary medicine
Brief summary
The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.
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.
Interventions
DRUGovaria comp 10 globuli 3 times per day 24 weeks
order of intervention and placebo varies between Groups I-III
Sponsors
Wala GmbH
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Climacteric symptoms | 12 weeks | sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II) | 12 weeks | 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 | 12+12 weeks | sum score and subscales of the MRS II |
| Follow-up for cross-over to placebo after 24 weeks of treatment | 12+12+12 weeks | sum score and subscales of the MRS II |
| Diurnal profile of cortisol level before and after treatment phases | 12+12+12 weeks | cortisol (saliva: morning, noon, evening) |
| Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period | 12+12+12 weeks | Hospital Anxiety and Depression Scale |
Countries
Germany
Outcome results
None listed