Green Tea Extract for Endometriosis Treatment

NCT ID: NCT02832271

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-08

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

green tea group

green tea extract SUNPHENON EGCg for women with ultrasound confirmed endometriosis

Group Type ACTIVE_COMPARATOR

SUNPHENON EGCg

Intervention Type DRUG

SUNPHENON EGCg Oral, 400mg, twice per day

placebo group

placebo fro women with ultrasound confirmed endometriosis

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SUNPHENON EGCg

SUNPHENON EGCg Oral, 400mg, twice per day

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

green tea extract

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ronald Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronald Wang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prince of Wales Hospital

Shatin, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6904267

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of KYG0395 on Primary Dysmenorrhea
NCT01588236 COMPLETED PHASE2