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Completed

NCT Number: NCT02832271

Green Tea Extract for Endometriosis Treatment

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Prince of Wales Hospital

Shatin, NT, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SUNPHENON EGCg

Drug

SUNPHENON EGCg Oral, 400mg, twice per day

Other names: green tea extract

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  1. Changes in pain scores assessed by ESS and VAS

    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. Changes in quality of life assessed by SF36

    Time frame: At 0, 1.5 and 3 months of treatment

    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.

  3. Change in endometriotic growth assessed by pathology

    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 assessed by DCE-MRI

    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 assessed by DCE-MRI

    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. Number of Participants with adverse outcome and side effects

    Time frame: At 0, 1.5 and 3 months of treatment

    any related and unrelated severe adverse events and adverse events, side-effects

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Jiangxi University of Traditional Chinese Medicine
  • Sun Yat-sen University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2016
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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