A Clinical Trial to Test a Modified Traditional Chinese Herbal Medicine for the Treatment of Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis; Alternative and Complementary Medicine - Herbal remedies; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12619000807156
• Lead Sponsor: Metagenics (Aust) Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-03
• Study Completion: 2023-08-28
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

Laparoscopic visualisation/confirmation of endometriosis in the last five years.

- Have menstrual or non-menstrual pelvic pain rated greater than or equal to 2.5/10 on a numeric rating scale based off an average over one month via Endometriosis pain daily diary v3 scores.

- Report at least ONE of the following:
oDysmenorrhea (period pain),
oDyspareunia (pain during or after sexual intercourse),
oDyschezia (pain before or during bowel motion) OR
oDysuria (pain prior to or during urination).

- Willing to provide informed consent and adhere to the protocol.

- Able to travel to a Laverty Pathology collection centre for two blood tests.

- If sexually active, agreeing to use appropriate contraception to prevent pregnancy during the study period.

- Has internet access (either via a mobile, tablet or computer) for completing the Endometriosis Pain Daily Diary v3 scores.

Exclusion Criteria

- Have had endometriosis related surgery in the previous six months.

- Started the oral or injectable contraceptive pill, GnRH-a or danazol within the last three months.

- Started, stopped or changed dosage on any pharmaceutical medication or herbal/natural medicine targeting endometriosis symptoms (such as pregabalin, Nortriptyline, or other Chinese herbal medicine) in the previous three months.

- Having a known allergy or intolerance to any of the ingredients in Gynoclear™.

- Usage of anticoagulants (e.g. Warfarin, Heparin, Eliquis, Pradaxa, Xarelto) or any other medication, including supplements (e.g., Vitamin E, Gingko), that causes blood thinning.

- History of coagulation disorders.

- Currently pregnant or breast feeding or planning on becoming pregnant during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified