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

This study will evaluate the efficacy of Gynoclear ™ by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores.MethodsThis 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 5  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 areCarthamus tinctorius (Safflower),Cinnamomum cassia (Chinese cinnamon),Poria cocos (Hoelen),Paeonia suffriticosa (Tree peony),Paeonia lactiflora (Peony) andSalvia miltiorrhiza (Red sage). Participants are asked to complete a total of 5  months’ worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-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 q uality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD.DiscussionThis study will determine the safety and efficacy of Gynoclear ™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of ...
Source: Trials - Category: Research Source Type: clinical trials