MedTrace Logo

Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy

NCT02952742 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-12-26

No results posted yet for this study

Summary

This is a randomized, placebo-controlled crossover study. Participants will be actively participating in the study for 6 months, and enrolled in the study for up to 1 year. During the first phase of the study, the participants will be randomized into either the placebo group or treatment group for 8 weeks following 1 week of baseline data collection (no treatment). Following this first phase, a no-treatment washout period of at least 3 weeks will be implemented for all participants. After the washout period, the randomized groups will switch from treatment to placebo group, or placebo to treatment group for an additional 8 week period. Hot flash frequency and severity will be documented using a daily hot flash diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaires.

Conditions

Interventions

DRUG

Black Cohosh

Vital Nutrients Black Cohosh Extract

OTHER

Placebo

Inactive comparator resembling the Black Cohosh formulation in appearance. Ingredients include: cellulose; caramel color; powdered yellow dye; and powdered red dye.

Sponsors & Collaborators

  • Midwestern Regional Medical Center

    lead OTHER

Principal Investigators

  • Evan Pisick, MD · Midwestern Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-11-30
Completion
2018-11-30

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 NCT02952742 on ClinicalTrials.gov