Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms

Efficacy of Menopause Relief EP-40 - Fixed Combination of Cimicifuga EP-40 and Rhodiola EPR-7 Extracts in Women With Menopausal Symptoms: A Randomized, Double Blind, Placebo Controlled Study

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.

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.

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