Menopause
Conditions
Keywords
Cimicifuga, Rhodiola, Menopause Symptoms
Brief summary
This study compares the efficacy of a fixed combination of black cohosh (EP-40) and Rhodiola rosea (EPR-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh extract only in adult woman with menopausal complaints.
Detailed description
Due to the problems caused by Hormone Replacement Therapy with chemical entities, some medicinal plants used in the traditional systems of medicine have shown immense potential in non-hormonal treatment of menopausal symptoms without major adverse events. We hypothesize that Menopause Relief EP-40 (a fixed combination of Cimicifuga EP-40 and Rhodiola EPR-7 extracts) will significantly relieve menopausal complaints such as hot flushes, profuse sweating hot flushes, excessive perspiration, night sweats, sleep disorders, nervousness, mood swings, physical and mental fatigue as compared to EP-40® capsules or placebo in adult females in menopause.
Interventions
DIETARY_SUPPLEMENTMenopause Relief EP-40
Fixed combination of black cohosh and Rhodiola rosea
DIETARY_SUPPLEMENTLow Dose Black Cohosh
6.5 mg black cohosh
DIETARY_SUPPLEMENTHigh Dose Black Cohosh
500 mg black cohosh
DIETARY_SUPPLEMENTPlacebo
600 mg excipient
Sponsors
I.Zhordania Institute of Reproductology
EuroPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
41 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of menopausal female climacteric states (N95.1 according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision, ICD-10, Version for 2014) which is characterized by symptoms such as flushing, sleeplessness, headache, lack of concentration associated with menopause, etc * Patients suffering from menopausal syndrome with neurovegetative components which have been stable anamnestically during the last 2 weeks * No medication taken for management of menopausal syndrome with neurovegetative components during the last 4 weeks * Ability to understand and provide signed informed consent * Ability to participate in the study * In some cases, diagnosis should be confirmed by blood tests of follicle-stimulating hormone (≥ 40 IU/L) \[postmenopausal status\], thyroid function with normal serum free T4 (fT4), estrogen (estrodiol levels) \[premenopausal 30-400 pg/mL; after menopause \<30 pg/mL\]
Exclusion criteria
* subjects with previous or current psychological disease that could interfere with their ability to participate in the study * anamnestic or current alcohol or drug abuse * concomitant treatment with psychotropic (in particular benzodiazepines, antidepressants, hypnotics or neuroleptics, tamoxifen, clomiphene, and danazol) or hormonally acting drugs such as hormone replacement therapy (HRT) * hyperthyroidism * malignant tumors * continuous climacteric bleeding and complaints related to myomas * patients who have taken another experimental drug within a 4-week period prior to the trial * pregnancy/lactation * serious internal disease * previous organ transplantation * premenopausal women with insufficient contraceptive protection * hypersensitivity to one of the ingredients of the trial medication * a body mass index of \>30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kupperman Menopausal Index (KMI) | 12 weeks | A modified total Kupperman Index (KMI) score and its sub-items will be used. It is a 10-item questionnaire of single symptoms with scores ranging from 0 to 3 (none, mild, moderate and severe). Total KMI is defined as the sum of sub-item scores multiplied by any weighting factors. The maximum value of the total KMI is 48. The primary outcome will be the difference in the changes from baseline to the end of therapy (week 12), between verum groups and placebo, assessed by the total KMI and stratified by individual baseline scores in an intention-to-treat (ITT) analysis (patients treated with study medication and with at least one efficacy assessment after baseline). |
| Menopause Rating Scale (MRS) | 12 weeks | The MRS is a patient reported assessment of 11 symptoms of menopause on a scale of 0 (none) to 4 (very severe). The MRS groups symptoms into three subscales: psychological, somatic, and urogenital. A composite score is calculated by adding the items in each dimension (subscale). The total score is the sum of the three dimensional scores. The primary outcome will be the difference in the changes from baseline to the end of therapy (week 12), between both verum groups and placebo, assessed by the MRS and stratified by individual baseline scores in an intention-to-treat (ITT) analysis (patients treated with study medication and with at least one efficacy assessment after baseline). |
Countries
Georgia
Outcome results
None listed