Green Tea Extract for Endometriosis Treatment

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832271
• Other study ID #: 6904267
• Status: Completed
• Phase: Phase 2
• Start date: December 8, 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• SUNPHENON EGCg
SUNPHENON EGCg Oral, 400mg, twice per day
• Placebo
Placebo

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (5)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	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

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in pain scores assessed by ESS and VAS	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.	At 0, 1.5 and 3 months of treatment
Secondary	Changes in quality of life assessed by SF36	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.	At 0, 1.5 and 3 months of treatment
Secondary	Change in endometriotic growth assessed by pathology	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.	At 0 and 3 months of treatment
Secondary	Change in total number of neovasculatures assessed by DCE-MRI	Subjects will undergo pelvic DCE-MRI for measurement of the total number of neovasculatures in the endometriotic mass.	At 0 and 3 months of treatment
Secondary	Change in density of neovasculatures assessed by DCE-MRI	Subjects will undergo pelvic DCE-MRI for measurement of the density of neovasculatures in the endometriotic mass.	At 0 and 3 months of treatments
Secondary	Number of Participants with adverse outcome and side effects	any related and unrelated severe adverse events and adverse events, side-effects	At 0, 1.5 and 3 months of treatment