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Study protocol
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.
Mike Armour
Western Sydney University
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7539-9851
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.
Keywords
Endometriosis, Gynoclear, Chinese Herbal Medicine, Pelvic Pain
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CURRENT STATUS: Under Review
Version 1
Posted 16 Dec, 2020
No community comments so far
Reviewer #2 agreed
On 29 Dec, 2020
Reviewers invited
Invitations sent on 29 Dec, 2020
Reviewer #1 agreed
On 29 Dec, 2020
Editor assigned
On 21 Dec, 2020
Submission checks complete
On 14 Dec, 2020
First submitted
On 28 Sep, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
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.
Mike Armour
Western Sydney University
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7539-9851
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 16 Dec, 2020
No community comments so far
Reviewer #2 agreed
On 29 Dec, 2020
Reviewers invited
Invitations sent on 29 Dec, 2020
Reviewer #1 agreed
On 29 Dec, 2020
Editor assigned
On 21 Dec, 2020
Submission checks complete
On 14 Dec, 2020
First submitted
On 28 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.