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Green Tea Extract: a Non-Surgical Alternative for Treatment of Uterine Fibroids

NCT01311869 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-10-24

No results posted yet for this study

Summary

Uterine Leiomyomata, also known as uterine fibroids, are non-cancer tumors found in the wall of the uterus or womb. Uterine fibroids are the common cause of surgery (removal of the uterus). African American women are 3-4 times more likely to have uterine fibroids. Currently there is no effective long-term medical treatment for fibroids. Hormones have been used for short-term therapy, but they are not used long-term because of the risk of side effects. When women stop receiving the hormone therapy often fibroids return. Surgery is the common treatment for women who are suffering from abnormal symptoms caused by fibroids. Hysterectomy is an effective treatment, however women cannot have children after removal of the uterus.

Epigallocatechin Gallate (EGCG) is one of the main natural chemicals found in green tea.. Research the investigators have done in the laboratory and in animals leads them to believe EGCG may decrease the growth of fibroids.

This study is intended to determine whether EGCG will cause fibroid tumors to shrink and reduce fibroid related symptoms such as abnormal vaginal bleeding and pelvic discomfort.

Conditions

  • Leiomyoma

Interventions

DIETARY_SUPPLEMENT

EGCG ( Green Tea extract)

A randomized double-blind placebo-controlled clinical trial will be conducted with 80 women of reproductive age,the 80 women will be allocated into two groups, 40 each. Each group will be given one of two interventions: The first is 2 capsules of (EGCG which is green tea extract, taken orally with food on daily basis for 6 months, each capsule contain 326.25 mg decaffeinated EGCG,The second group will receive matched (color, taste and texture) placebo for a period of 6 months.

DIETARY_SUPPLEMENT

Brown rice pills

40 subjects will receive 800 mg EGCG orally daily for 6 months, the other 40 subject will receive brown rice pills for the same duration.

Sponsors & Collaborators

  • Meharry Medical College

    lead OTHER

Principal Investigators

  • Ayman Al-Hendy, MD, PhD · Meharry Medical College

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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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 NCT01311869 on ClinicalTrials.gov