Green Tea Extract for Endometriosis Treatment
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|ClinicalTrials.gov Identifier: NCT02832271|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Drug: SUNPHENON EGCg Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomised Double-blinded Placebo Controlled Trial of Green Tea Extract for Endometriosis|
|Actual Study Start Date :||December 8, 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Active Comparator: green tea group
green tea extract SUNPHENON EGCg for women with ultrasound confirmed endometriosis
Drug: SUNPHENON EGCg
SUNPHENON EGCg Oral, 400mg, twice per day
Other Name: green tea extract
Placebo Comparator: placebo group
placebo fro women with ultrasound confirmed endometriosis
- 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 changes in endometriotic mass after treatment.
- Changes in pain scores assessed by ESS and VAS [ Time Frame: At 0, 1.5 and 3 months of treatment ]The severity of the pain will be quantified and evaluated by an Endometriosis Symptom Severity verbal rating scale (ESS). With ESS, subjects will rate their pain from score 0 as absence of pain to 10 as the most severe intolerable pain. A modified Biberoglu-Behrman 10cm visual analogue scale (VAS) will also be used to evaluate the pain experienced by the subjects. For VAS, subjects will mark the level of pain that they encounter on a graphic scale which range from 0cm as absence of pain to 10cm as the pain becomes as bad as it could possibly be. The 2 measurements will be recorded separately.
- Changes in quality of life assessed by SF36 [ Time Frame: At 0, 1.5 and 3 months of treatment ]Quality of life will be assessed using the standard SF36 instrument. SF36 consists of a medical survey which consists of 8 domains. The domain scores are rated onto a scale from 0 as worst health to 100 as best health. The Endometriosis Health Profile version 5 (EHP5) will as well be used to assess the quality of life. EHP5 contains 5 core and 6 modular questionnaires. Each item is rated on a 5-point scale (from 0=never to 4=always). The overall score will be transformed to a scale of 0 as best health and 100 as worst health.
- Change in endometriotic growth assessed by pathology [ Time Frame: At 0 and 3 months of treatment ]Endometriotic cysts biopsies will be collected during the surgery. Endometriotic growth will be confirmed by the presence of endometrial epithelial glands and stroma in the biopsies. The biopsies will be compared to the endometriotic mass before treatment.
- Change in total number of neovasculatures assessed by DCE-MRI [ Time Frame: At 0 and 3 months of treatment ]Subjects will undergo pelvic DCE-MRI for measurement of the total number of neovasculatures in the endometriotic mass.
- Change in density of neovasculatures assessed by DCE-MRI [ Time Frame: At 0 and 3 months of treatments ]Subjects will undergo pelvic DCE-MRI for measurement of the density of neovasculatures in the endometriotic mass.
- Number of Participants with adverse outcome and side effects [ Time Frame: At 0, 1.5 and 3 months of treatment ]any related and unrelated severe adverse events and adverse events, side-effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832271
|Contact: Ronald Wang, MD, PhD||+852 2632 firstname.lastname@example.org|
|Prince of Wales Hospital||Recruiting|
|Shatin, Hong Kong, NT|
|Contact: Hui Xu, MD, PhD|
|Principal Investigator:||Ronald Wang, MD PhD||Chinese University of Hong Kong|