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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 : July 25, 2019
Sponsor:
Collaborators:
University of Chinese Academy of Sciences
Sun Yat-sen University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Jiangxi University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Ronald Wang, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE July 5, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE December 8, 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Adverse events [ Time Frame: At 0, 1.5 and 3 months of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Green Tea for Endometriosis
Official Title  ICMJE Randomised Double-blinded Placebo Controlled Trial of Green Tea Extract for Endometriosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: SUNPHENON EGCg
    SUNPHENON EGCg Oral, 400mg, twice per day
    Other Name: green tea extract
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: green tea group
    green tea extract SUNPHENON EGCg for women with ultrasound confirmed endometriosis
    Intervention: Drug: SUNPHENON EGCg
  • Placebo Comparator: placebo group
    placebo fro women with ultrasound confirmed endometriosis
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2016)
185
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ronald Wang, MD, PhD +852 2632 2810 ccwang@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02832271
Other Study ID Numbers  ICMJE 6904267
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ronald Wang, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE
  • University of Chinese Academy of Sciences
  • Sun Yat-sen University
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Jiangxi University of Traditional Chinese Medicine
Investigators  ICMJE
Principal Investigator: Ronald Wang, MD PhD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP