Back to resultsGreen Tea Extract for Endometriosis Treatment
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
SUNPHENON EGCg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
green tea group
placebo group
Arm Description
green tea extract SUNPHENON EGCg for women with ultrasound confirmed endometriosis
placebo fro women with ultrasound confirmed endometriosis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Number of Participants with adverse outcome and side effects
any related and unrelated severe adverse events and adverse events, side-effects
Full Information
NCT ID
NCT02832271
First Posted
July 5, 2016
Last Updated
February 6, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-sen University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jiangxi University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02832271
Brief Title
Green Tea Extract for Endometriosis Treatment
Official Title
Randomised Double-blinded Placebo Controlled Trial of Green Tea Extract for Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-sen University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jiangxi University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of green tea in endometriosis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
green tea group
Arm Type
Active Comparator
Arm Description
green tea extract SUNPHENON EGCg for women with ultrasound confirmed endometriosis
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo fro women with ultrasound confirmed endometriosis
Intervention Type
Drug
Intervention Name(s)
SUNPHENON EGCg
Other Intervention Name(s)
green tea extract
Intervention Description
SUNPHENON EGCg Oral, 400mg, twice per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in endometriotic lesion size
Description
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.
Time Frame
At 0 and 3 months of treatment
Secondary Outcome Measure Information:
Title
Changes in pain scores assessed by ESS and VAS
Description
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.
Time Frame
At 0, 1.5 and 3 months of treatment
Title
Changes in quality of life assessed by SF36
Description
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.
Time Frame
At 0, 1.5 and 3 months of treatment
Title
Change in endometriotic growth assessed by pathology
Description
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.
Time Frame
At 0 and 3 months of treatment
Title
Change in total number of neovasculatures assessed by DCE-MRI
Description
Subjects will undergo pelvic DCE-MRI for measurement of the total number of neovasculatures in the endometriotic mass.
Time Frame
At 0 and 3 months of treatment
Title
Change in density of neovasculatures assessed by DCE-MRI
Description
Subjects will undergo pelvic DCE-MRI for measurement of the density of neovasculatures in the endometriotic mass.
Time Frame
At 0 and 3 months of treatments
Title
Number of Participants with adverse outcome and side effects
Description
any related and unrelated severe adverse events and adverse events, side-effects
Time Frame
At 0, 1.5 and 3 months of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Wang, MD PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
NT
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Green Tea Extract for Endometriosis Treatment
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