Clinical trial · Interventional
Green Tea Extract: a Non-Surgical Alternative for Treatment of Uterine Fibroids
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB Decision
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brown rice pills | Dietary Supplement | — | UNRESOLVED |
| EGCG ( Green Tea extract) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EGCG ( Green Tea extract)
- description
- 40 subjects will receive 800 mg EGCG orally per day for 6 months versus 40 subjects will receive Brown Rice pill for 6 months
- interventionNames
- Dietary Supplement: EGCG ( Green Tea extract)
- Dietary Supplement: Brown rice pills
- type
- PLACEBO_COMPARATOR
- label
- Brown Rice pills
- description
- 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
- interventionNames
- Dietary Supplement: EGCG ( Green Tea extract)
- Dietary Supplement: Brown rice pills
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJohnson JJ, Siblini H, Al-Hendy A, Segars JH, Gonzalez F, Taylor HS, Singh B, Carson SA, Christman GM, Huang H, Dangi B, Zhang H. Evaluating the Effect of Epigallocatechin Gallate (EGCG) in Reducing Folate Levels in Reproductive Aged Women by MTHFR and DHFR Genotype in Combination With Letrozole or Clomiphene. Clin Transl Sci. 2025 Mar;18(3):e70189. doi: 10.1111/cts.70189. PMID 40077973