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Green Tea for Endometriosis

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ClinicalTrials.gov Identifier: NCT02832271
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ronald Wang, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: SUNPHENON EGCg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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 Name: green tea extract

Placebo Comparator: placebo group
placebo fro women with ultrasound confirmed endometriosis
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain scores [ 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.

  2. Quality of life [ Time Frame: At 0, 1.5 and 3 months of treatment ]
    Quality of life will be assessed using the standard SF36 instrument. SP36 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.

  3. Change in endometriotic growth [ 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.

  4. Change in total number of neovasculatures [ 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.

  5. Change in density of neovasculatures [ 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.

  6. Adverse events [ Time Frame: At 0, 1.5 and 3 months of treatment ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Ronald Wang, MD, PhD +852 2632 2810 ccwang@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong, NT
Contact: Hui Xu, MD, PhD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Ronald Wang, MD PhD Chinese University of Hong Kong

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Responsible Party: Ronald Wang, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02832271     History of Changes
Other Study ID Numbers: 6904267
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female