NCT02832271

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 8, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 years

First QC Date

July 5, 2016

Last Update Submit

February 6, 2023

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Changes in pain scores assessed by ESS and VAS

    At 0, 1.5 and 3 months of treatment

  • Changes in quality of life assessed by SF36

    At 0, 1.5 and 3 months of treatment

  • Change in endometriotic growth assessed by pathology

    At 0 and 3 months of treatment

  • Change in total number of neovasculatures assessed by DCE-MRI

    At 0 and 3 months of treatment

  • Change in density of neovasculatures assessed by DCE-MRI

    At 0 and 3 months of treatments

  • +1 more secondary outcomes

Study Arms (2)

green tea group

ACTIVE COMPARATOR

green tea extract SUNPHENON EGCg for women with ultrasound confirmed endometriosis

Drug: SUNPHENON EGCg

placebo group

PLACEBO COMPARATOR

placebo fro women with ultrasound confirmed endometriosis

Drug: Placebo

Interventions

SUNPHENON EGCgDRUG

SUNPHENON EGCg Oral, 400mg, twice per day

Also known as: green tea extract
green tea group
PlaceboDRUG

Placebo

placebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, NT, Hong Kong

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Tea

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ronald Wang, MD PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 14, 2016

Study Start

December 8, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)