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

NCT03461380 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2020-04-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • I.Zhordania Institute of Reproductology

    collaborator UNKNOWN
  • EuroPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Lali Phkhaladze, PhD, MD · I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-09-30
Completion
2019-10-01

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461380 on ClinicalTrials.gov