Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms
NCT ID: NCT00066144
Last Updated: 2007-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2003-04-30
2006-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cimicifuga racemosa
Trifolium pratense
Black cohosh
Red clover
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be experiencing hot flashes
* No menstrual periods for at least 6 months and no longer than 3 years
* Non-smoker
* Must have intact uterus (no hysterectomy)
Exclusion Criteria
* Diabetes mellitus
* Pregnancy or breast-feeding
* Obese (BMI \>35 excluded)
* History of endometrial hyperplasia/neoplasia/malignancy
* History of breast or reproductive cancer
* History of severe recurrent depression, or severe psychiatric disturbance
* History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
* History of abnormal vaginal bleeding of unknown cause
* Untreated or uncontrolled high blood pressure/hypertension
* Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
* History of hormone-associated migraines
* History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
* Participation in a clinical trial within 30 days
* Abnormal endometrial biopsy or mammogram
* Abnormal transvaginal ultrasound defined as \>7mm thickness
* Vegan
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Office of Dietary Supplements (ODS)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stacie Geller, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology University of Illinois, Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Illinois at Chicago
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Geller SE, Shulman LP, van Breemen RB, Banuvar S, Zhou Y, Epstein G, Hedayat S, Nikolic D, Krause EC, Piersen CE, Bolton JL, Pauli GF, Farnsworth NR. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009 Nov-Dec;16(6):1156-66. doi: 10.1097/gme.0b013e3181ace49b.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.