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

Abstract Background Endometriosis is the presence of tissue similar to that endometrium outside uterine cavity and most common cause chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills hormonal have limited effectiveness, side effect profile bothersome. This study will evaluate efficacy Gynoclear™ by change in endometriosis-related pain based on Pain Daily Diary (EPPD) scores. Methods randomised, double-blind, placebo-controlled trial recruit a minimum 90 adult participants across Australia who laparoscopic visualisation/confirmation endometriosis last 5 years current moderate or greater Participants be randomly allocated 1:1 ratio receive either (active) placebo. Gyncolear’s active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), lactiflora (Peony) Salvia miltiorrhiza (Red sage). asked complete total months’ worth diary entries via EPDD v3, including 1-month screening, 2-month treatment period post-treatment follow-up. The primary outcome variable v3 Secondary outcomes include health-related quality life Health Profile (EHP-30), SF-12 EQ-5D scores well changes rescue analgesic usage, dyspareunia fatigue EPDD. Discussion determine safety reduce severity duration non-cyclical pain, dysmenorrhoea, other symptoms endometriosis. Study interest health professionals members public suffer from Trial registration New Zealand Clinical Trials Registry ACTRN12619000807156 . Registered 3 June 2019.