Green Tea Extract for Endometriosis Treatment

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

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

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: SUNPHENON EGCg; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong, NT
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: green tea extract
PLACEBO_COMPARATOR: placebo group; placebo fro women with ultrasound confirmed endometriosis	Drug: Placebo; Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Jiangxi University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2016
• Primary Completion (ACTUAL): December 1, 2022
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (ESTIMATE): July 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 6904267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No