Clinical trial NCT02832271: Green Tea Extract for Endometriosis Treatment
Official title: Randomised Double-blinded Placebo Controlled Trial of Green Tea Extract for Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Sun Yat-sen University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Jiangxi University of Traditional Chinese Medicine
First posted: 2016-07-14
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in endometriotic lesion size
timeFrame: At 0 and 3 months of treatment
Secondary outcomes:
measure: Changes in pain scores assessed by ESS and VAS
timeFrame: At 0, 1.5 and 3 months of treatment
measure: Changes in quality of life assessed by SF36
timeFrame: At 0, 1.5 and 3 months of treatment
measure: Change in endometriotic growth assessed by pathology
timeFrame: At 0 and 3 months of treatment
measure: Change in total number of neovasculatures assessed by DCE-MRI
timeFrame: At 0 and 3 months of treatment
measure: Change in density of neovasculatures assessed by DCE-MRI
timeFrame: At 0 and 3 months of treatments
measure: Number of Participants with adverse outcome and side effects
timeFrame: At 0, 1.5 and 3 months of treatment
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Ronald Wang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: