NCT02832271

Randomised Double-blinded Placebo Controlled Trial of Green Tea Extract for Endometriosis

Completed Phase 2 Last updated 6 February 2023

What this trial tests

Phase 2 trial testing SUNPHENON EGCg in Endometriosis in 185 participants. Completed in 1 December 2022.

Timeline

8 December 2016

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	185
Start date	8 December 2016
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	1 location across Hong Kong

Drugs / interventions tested

• SUNPHENON EGCg — full drug profile →
• Placebo

Conditions studied

• Endometriosis — all drugs for Endometriosis →

Sponsor

Chinese University of Hong Kong

Who can join

Adults 18 to 40, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in endometriotic lesion size
  Time frame: At 0 and 3 months of treatment
  Structural MRI will be performed with a 3T whole-body clinical scanner by a radiologist. The total volume of endometriotic mass in the endometrioma indicated by the positive enhanced image will be quantified. The endometriotic mass before treatment will be used as baseline for comparison and analysis. Prior to the planned surgery, another structural MRI will be performed again to assess the change

Sponsor's own description

The purpose of the study is to evaluate the efficacy and safety of green tea in endometriosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmaceuticals targeting signaling pathways of endometriosis as potential new medical treatment: A review.
   Hung SW, Zhang R, Tan Z, Chung JPW, et al · · 2021 · cited 120× · PMID 33948974 · DOI 10.1002/med.21802
2. Chronic Niche Inflammation in Endometriosis-Associated Infertility: Current Understanding and Future Therapeutic Strategies.
   Lin YH, Chen YH, Chang HY, Au HK, et al · · 2018 · cited 102× · PMID 30104541 · DOI 10.3390/ijms19082385
3. Diet and Nutrition in Gynecological Disorders: A Focus on Clinical Studies.
   Afrin S, AlAshqar A, El Sabeh M, Miyashita-Ishiwata M, et al · · 2021 · cited 59× · PMID 34063835 · DOI 10.3390/nu13061747
4. Polyphenols as a Diet Therapy Concept for Endometriosis-Current Opinion and Future Perspectives.
   Gołąbek A, Kowalska K, Olejnik A. · · 2021 · cited 38× · PMID 33919512 · DOI 10.3390/nu13041347
5. Green Tea and Benign Gynecologic Disorders: A New Trick for An Old Beverage?
   Hazimeh D, Massoud G, Parish M, Singh B, et al · · 2023 · cited 17× · PMID 36986169 · DOI 10.3390/nu15061439
6. Epigallocatechin Gallate for the Treatment of Benign and Malignant Gynecological Diseases-Focus on Epigenetic Mechanisms.
   Włodarczyk M, Ciebiera M, Nowicka G, Łoziński T, et al · · 2024 · cited 16× · PMID 38398883 · DOI 10.3390/nu16040559
7. New therapeutic approaches for endometriosis besides hormonal therapy.
   Chen FY, Wang X, Tang RY, Guo ZX, et al · · 2019 · cited 16× · PMID 31809322 · DOI 10.1097/cm9.0000000000000569
8. The Hallmarks of Endometriosis.
   Psilopatis I, Burghaus S, Au K, Hofbeck L, et al · · 2024 · cited 6× · PMID 38884026 · DOI 10.1055/a-2306-8759