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

This study has been terminated.
(IRB Decision)
Sponsor:
Information provided by (Responsible Party):
Ayman Al-Hendy, Meharry Medical College
ClinicalTrials.gov Identifier:
NCT01311869
First received: March 7, 2011
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Leiomyoma
Dietary Supplement: EGCG ( Green Tea extract)
Dietary Supplement: Brown rice pills
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Green Tea Extract: a Non-Surgical Alternative for Treatment of Uterine Fibroids

Resource links provided by NLM:


Further study details as provided by Meharry Medical College:

Primary Outcome Measures:
  • fibroid size [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Every month for 6 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EGCG ( Green Tea extract)
40 subjects will receive 800 mg EGCG orally per day for 6 months versus 40 subjects will receive Brown Rice pill for 6 months
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.
Other Name: EGCG ( Green Tea extract)
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.
Placebo Comparator: Brown Rice pills
40 subjects will receive 800 mg brown rice pills orally per day for 6 months versus 40 subjects will receive EGCG capsule for 6 months
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.
Other Name: EGCG ( Green Tea extract)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female; Age: 18Y or older.
  • Pre-menopausal.
  • FSH level is less than 10 mIU/L.
  • Have at least moderate uterine fibroid-related symptoms (score of 24 or higher according to UFS-QOL questionnaire.
  • Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is ≥ 2.5cm in diameter.
  • Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy.
  • Agree to report any pregnancy to the research staff immediately.
  • Willing and able to give informed consent.
  • Willing and able to comply with study requirements.
  • Liver function (ALT, AST, Prothrombin time and concentration)to be≤ 1.5 times the upper limit of normal

Exclusion Criteria:

  • Current or planned pregnancy during the study period.
  • Menopausal, as indicated by elevated follicle stimulating hormone (FSH) serum level.
  • Currently breast-feeding.
  • Untreated abnormal pap smear.
  • Presence of conditions other than fibroids contributing to pelvic pain and/or bleeding;
  • Hemoglobin < 8.0 mg/dl.
  • Presence of adnexal masses or tenderness indicating the need for further evaluation or surgery.
  • Grade III or IV hydronephrosis by ultrasound.
  • Mental health disorder.
  • Active substance abuse or dependence.
  • Current or recent (within the past 3 months) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, Herbal or botanical supplements with possible hormonal or EGCG effects. Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera,
  • Current or planned use during the study of any of the following medications/or products: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampin, St John's Wort, phenytoin, phenobarbital, or carbamazepine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311869

Locations
United States, Tennessee
Meharry Medical College
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Meharry Medical College
Investigators
Principal Investigator: Ayman Al-Hendy, MD, PhD Meharry Medical College
  More Information

No publications provided

Responsible Party: Ayman Al-Hendy, Principal Investigator, Meharry Medical College
ClinicalTrials.gov Identifier: NCT01311869     History of Changes
Other Study ID Numbers: Green Tea Study
Study First Received: March 7, 2011
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 23, 2014