A placebo controlled, double blind, randomised controlled trial to evaluate the treatment efficacy of a modified Gui Zhi Fu Ling Wan formulation (GynoclearTM) in women with endometriosis

Metagenics (Aust) Pty Ltd0 个研究点目标入组 93 人开始时间: 2019年6月3日最近更新: 2023年10月16日

适应症

试验速览

暂无简介。

•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.

•- 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.

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