Green Tea Extract for Endometriosis Treatment

The Chinese University of Hong Kong

Status and phase

Completed

Phase 2

Conditions

Endometriosis

Treatments

Drug: SUNPHENON EGCg

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02832271

6904267

Details and patient eligibility

About

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

Full 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.

Enrollment

185 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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