NCT03461380

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: EuroPharma, Inc. · Industry
• Sex: Female
• Age: 41 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Menopause Relief EP-40	Fixed combination of black cohosh and Rhodiola rosea
DIETARY_SUPPLEMENT	Low Dose Black Cohosh	6.5 mg black cohosh
DIETARY_SUPPLEMENT	High Dose Black Cohosh	500 mg black cohosh
DIETARY_SUPPLEMENT	Placebo	600 mg excipient

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-09-30
• Completion: 2019-10-01
• First posted: 2018-03-12
• Last updated: 2020-04-28

Locations

1 site across 1 country: Georgia