Skip to main content

Table 1 Inclusion and exclusion criteria

From: The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial

Inclusion criteria:

 Age 18–45 years.

 Laparoscopic visualisation/confirmation of endometriosis in the last 5 years.

 Have menstrual or non-menstrual pelvic pain rated ≥4/10 on a numeric rating scale based on an average over 1 month via endometriosis pain daily diary (version 3) scores.

 Report at least ONE of the following:

  Dysmenorrhoea (period pain),

  Dyspareunia (pain during or after sexual intercourse),

  Dyschezia (pain before or during bowel motion) OR

  Dysuria (pain prior to or during urination).

 Willing to provide informed consent and adhere to the protocol.

 Able to travel to a Laverty Pathology (or its sister companies) collection centre for two blood tests; one at baseline and the second at the end of the intervention approximately 12 weeks later

 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 6 months or have any surgery planned during the study period.

 Started or stopped/removed any hormonal contraceptive within the last 6 months. This includes the oral contraceptive pill (GnRH-a or danazol), implant contraceptives and the Mirena.

 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 6 months

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

 Participant has previously used Gynoclear™ for any condition.

 Participant is currently using a herbal supplement that contains any of the main constituents of the Gynoclear™ formula (e.g. Mediherb Endofem).

 Usage of anticoagulants (e.g. Warfarin, Heparin, Eliquis, Pradaxa, Xarelto) or any other medication, including nutritional and/or herbal supplements that may cause blood thinning (e.g. Vitamin E, Gingko biloba).

 History of coagulation disorders.

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