Green Tea Extract for Endometriosis Treatment

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

Detailed Description
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Women with endometrioma will be randomised into either the experimental group or the placebo comparator group in a 1:1 ratio. The subjects will be given SUNPHENON EGCg or placebo for 3 months prior to their planned surgery.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: SUNPHENON EGCg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complaints of pelvic pain, dysmenorrhoea and/or dyspareunia ≥ 6 months; and Verbal pain rating scale > 4/10 and visual analogue pain scale > 4cm; and Ultrasound confirmed endometrioma with or without fibroid and adenomyoma; and Planned surgery treatment within 4-6 months Exclusion Criteria: Age < 20 years beyond or >40 year behind the active reproductive age; or BMI <18.5 kg/m2 as underweight or >25 kg/m2 as overweight; or Chronic pelvic pain or low back pain due to other medical conditions, e.g. urological disorders and orthopaedic disorders; or Secondary dysmenorrhoea due to gynaecological conditions other than endometriosis, e.g. pelvic inflammatory diseases, genitourinary infections, gynaecological tumours, etc.; or Primary dysmenorrhoea without any underlying disease identified; or Ultrasound suggested polycystic ovary, haemorrhagic ovarian cyst, ovarian dermoid cyst, cystic neoplasm, tubo-ovarian abscess or other ovarian pathologies in the same ovary; or Chronic medical conditions under long-term medications; or Endometriosis under active medication in past 1 month; or History of herbal medicine intake in past 1 month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: green tea group<br>green tea extract SUNPHENON EGCg for women with ultrasound confirmed endometriosis | Drug: SUNPHENON EGCg<br>* SUNPHENON EGCg Oral, 400mg, twice per day<br>* Other names: green tea extract;|
| Placebo Comparator: placebo group<br>placebo fro women with ultrasound confirmed endometriosis | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endometriotic lesion size | 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. | At 0 and 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain scores assessed by ESS and VAS | 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. | At 0, 1.5 and 3 months of treatment | 
| Changes in quality of life assessed by SF36 | 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. | At 0, 1.5 and 3 months of treatment | 
| Change in endometriotic growth assessed by pathology | 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. | At 0 and 3 months of treatment | 
| Change in total number of neovasculatures assessed by DCE-MRI | Subjects will undergo pelvic DCE-MRI for measurement of the total number of neovasculatures in the endometriotic mass. | At 0 and 3 months of treatment | 
| Change in density of neovasculatures assessed by DCE-MRI | Subjects will undergo pelvic DCE-MRI for measurement of the density of neovasculatures in the endometriotic mass. | At 0 and 3 months of treatments | 
| Number of Participants with adverse outcome and side effects | any related and unrelated severe adverse events and adverse events, side-effects | At 0, 1.5 and 3 months of treatment |