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.

Background: Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills, and hormonal treatments have limited effectiveness and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis related pain based on the Endometriosis Pain Daily Diary (EPPD) scores. Methods: This randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participants across Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last five years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear’s active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of five months’ worth of pain diary entries via the EPDD v3, including one-month screening, three-months treatment period and one-month post-treatment follow up. The primary outcome variable is change in endometriosis related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD. Discussion : This study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals, and members of the public who suffer from endometriosis. Trial registration: Australia and New Zealand Clinical Trials Registry, ACTRN12619000807156 (https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377571). Registered on 03-Jun-2019.