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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\u2122 by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      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 5\u00a0years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear\u2122 (active) or placebo. Gyncolear\u2019s active ingredients are\n                      <jats:italic>Carthamus tinctorius<\/jats:italic>\n                      (Safflower),\n                      <jats:italic>Cinnamomum cassia<\/jats:italic>\n                      (Chinese cinnamon),\n                      <jats:italic>Poria cocos<\/jats:italic>\n                      (Hoelen),\n                      <jats:italic>Paeonia suffriticosa<\/jats:italic>\n                      (Tree peony),\n                      <jats:italic>Paeonia lactiflora<\/jats:italic>\n                      (Peony) and\n                      <jats:italic>Salvia miltiorrhiza<\/jats:italic>\n                      (Red sage). Participants are asked to complete a total of 5\u00a0months\u2019 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 quality 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This study will determine the safety and efficacy of Gynoclear\u2122 to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals and members of the public who suffer from endometriosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Australia and New Zealand Clinical Trials Registry\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=377571\">ACTRN12619000807156<\/jats:ext-link>\n                      . Registered on 3 June 2019.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05265-x","type":"journal-article","created":{"date-parts":[[2021,4,21]],"date-time":"2021-04-21T08:22:32Z","timestamp":1618993352000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear\u2122) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7539-9851","authenticated-orcid":false,"given":"Mike","family":"Armour","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmoud A.","family":"Al-Dabbas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn","family":"Ee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline A.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Ussher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Arentz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenny","family":"Lawson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Abbott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,4,21]]},"reference":[{"key":"5265_CR1","volume-title":"Pelvic pain: diagnosis and management","author":"F Howard","year":"2000","unstructured":"Howard F, Perry P, Carter J, et al. 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Written, informed consent to participate will be obtained from all participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MA, MAD, CS and CE are part of NICM. As a medical research institute, NICM Health Research Institute receives research grants and donations from foundations, universities, government agencies, individuals and industry. Sponsors and donors also provide untied funding for work to advance the vision and mission of the Institute. The authors declare no competing financial interests. SA and JA are also in clinical practice. JA is the Medical Director of Endometriosis Australia. This is an honorary position with this not-for-profit organisation. JU and KL declare no conflicts of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"299"}}