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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
order of intervention and placebo varies between Groups I-III
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Wurttemberg, Germany
Climacteric symptoms
sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment
Time frame: 12 weeks
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
Time frame: 12 weeks
Follow-up for another 12 weeks of treatment or after cross-over to the placebo group
sum score and subscales of the MRS II
Time frame: 12+12 weeks
Follow-up for cross-over to placebo after 24 weeks of treatment
sum score and subscales of the MRS II
Time frame: 12+12+12 weeks
Diurnal profile of cortisol level before and after treatment phases
cortisol (saliva: morning, noon, evening)
Time frame: 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
Time frame: 12+12+12 weeks
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