Effects of Black Cohosh on Menopausal Hot Flashes

Status Completed

Clinical Trial Summary

This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.

Clinical Trial Description

Most American women will spend the last third of their lives post-menopause. During this time, chronically low levels of steroidal estrogens may lead to a number of short and long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and osteoporosis. While some physicians believe that demonstrated beneficial effects of estrogen, particularly on the cardiovascular and skeletal systems, warrant the taking of hormone therapy from menopause on, many women choose not to take estrogen replacement therapy (ERT) and are increasingly exploring alternative approaches to ERT.

For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's health. Despite its long-standing use, studies of black cohosh have yielded conflicting data, in part because of lack in study design rigor and the short duration of studies to date. The primary aim of this study is to correct past shortcomings in study design to determine whether treatment with black cohosh is effective in treating menopausal symptoms.

Participants in this study will be given black cohosh for a 12-month period. Potential mechanisms of action of black cohosh will be examined by quantifying the levels of sex hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring the incidence of adverse events and compliance with the study. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00010712
Study type	Interventional
Source	National Center for Complementary and Integrative Health (NCCIH)
Contact
Status	Completed
Phase	Phase 2
Start date	September 1999
Completion date	July 2005

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04587154` - Womens Study to Alleviate Vasomotor Symptoms	N/A
Terminated	`NCT03642119` - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed	`NCT05061563` - A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults	Phase 1
Completed	`NCT05419908` - Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes	Phase 2
Completed	`NCT01281332` - Mechanical Device for the Relief of Hot Flashes	Phase 2
Completed	`NCT01439945` - Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer	Phase 2
Completed	`NCT00755417` - Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women	Phase 3
Completed	`NCT01293695` - Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial	N/A
Completed	`NCT00599456` - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.	N/A
Completed	`NCT00256685` - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause	Phase 3
Completed	`NCT00391417` - Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms	Phase 3
Terminated	`NCT00244894` - Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer	N/A
Active, not recruiting	`NCT03580499` - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy	N/A
Recruiting	`NCT06030388` - Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women	N/A
Recruiting	`NCT04418115` - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option?	N/A
Recruiting	`NCT04861701` - Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise	N/A
Active, not recruiting	`NCT05086705` - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer	N/A
Completed	`NCT05099159` - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)	Phase 3
Completed	`NCT01140646` - Evaluation of SAMe for Hot Flashes	Phase 2
Completed	`NCT00956813` - Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy	Phase 3