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Gui Zhi Fu Ling Wan- Chinese Herbal Formula

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 | Trials | Full Text

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Summary of article content: Articles about 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 | Trials | Full Text Gui Zhi Fu Ling Wan is the most common Traditional Chinese herbal medicine prescription used in the treatment of endometriosis [23] and includes … …
Most searched keywords: Whether you are looking for 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 | Trials | Full Text Gui Zhi Fu Ling Wan is the most common Traditional Chinese herbal medicine prescription used in the treatment of endometriosis [23] and includes … 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. 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 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 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 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. This 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 interest to health professionals and members of the public who suffer from endometriosis. Australia and New Zealand Clinical Trials Registry ACTRN12619000807156 . Registered on 3 June 2019.
Table of Contents:

Abstract

Background

Methods

Discussion

Trial status

Availability of data and materials

Abbreviations

References

Acknowledgements

Funding

Author information

Ethics declarations

Additional information

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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 | Trials | Full Text

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Summary of article content: Articles about Guizhi Fuling Wan – Wikipedia Guizhi Fuling Wan is a brown pill used in Traditional Chinese medicine to “activate blood circulation, to remove blood stasis and mass in the abdomen”. …
Most searched keywords: Whether you are looking for Guizhi Fuling Wan – Wikipedia Guizhi Fuling Wan is a brown pill used in Traditional Chinese medicine to “activate blood circulation, to remove blood stasis and mass in the abdomen”.
Table of Contents:

Contents

History[edit]

Chinese classic herbal formula[edit]

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 –

A randomised, placebo-controlled, double-blind, clinical trial to evaluate the efficacy of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis-related pelvic pain. Australian ethics approval from Western Sydney University Human Research Ethics Committee, H13256 (approved May 2019). The trial was prospectively registered with the Australia New Zealand Clinical Trials Registry: ACTRN12619000807156. Recruitment began in June 2019 and is currently ongoing. Single centre study recruiting from all of Australia (NSW, VIC, WA, TAS, QLD and SA). Coordinating centre: NICM Health Research Institute at Western Sydney University, Penrith NSW 2751 Australia.

Participants

Eligible participants are aged 18 to 45, have a laparoscopic visualisation/confirmation of endometriosis in the last 5 years, self-reported menstrual or non-menstrual pelvic pain and at least one of the common endometriosis-related forms of pelvic pain will be recruited. Full inclusion and exclusion criteria are presented in Table 1.

Table 1 Inclusion and exclusion criteria Full size table

Based on a 20% difference in pain (measured by a 0–10 NRS) between groups (a moderate effect size d = 0.5 and a clinically significant difference), a standard deviation in pain scores of 2.2 (based on pilot data), an alpha of 0.05 and a power of 80% would mean 74 participants would need to be recruited. Given a predicted 20% drop out rate, 90 participants in total (45 per group) will be recruited. At the time of manuscript submission, 24 participants have been randomised.

Patient and public involvement

Two streams of focus groups were conducted to co-design the trial with key stakeholders. The two groups were women diagnosed with endometriosis (n = 67) and TCM, herbalist or naturopathic practitioners (n = 8). These groups provided input on feasibility, dosage, outcome measures and duration of the trial.

Recruitment and selection

Recruitment for this study is primarily via our partners Endometriosis Australia social media presence as well as paid Facebook advertising. All advertisements will advise participants of the trial and refer them to the Research Institute webpage. A link to a pre-screening survey will be available on the webpage to allow participants to self-screen against the inclusion and exclusion criteria of the study. All potentially eligible participants, based on their responses from the survey, will be instructed to schedule a call with the clinical trial officer or another member of the research team for follow-up procedures.

Potential participants will be required, after giving consent, to fill in a previously validated endometriosis daily pain diary (EPDD v3) [12] via an online secure electronic case report form hosted on Castor EDC. This diary will be filled in for 4 weeks and will fulfil two purposes:

1. Ensure that the participant meets the minimum pain requirements to enter the study and 2. If the participant is included in the study, this becomes the baseline/pre-treatment data for future analysis.

If eligible based on pain diary scores (averaged across 4 weeks), participants will be required to provide a copy of their most recent laparoscopy report and/or the gynaecologists report/letter that confirms visualisation of endometriosis. This must be within the previous 5 years of their entry into the trial. Upon receipt of the completed EPDD and the proof of surgical confirmation, participants will be included in the study.

Randomisation

After signing the informed consent document and satisfying the eligibility criteria, participants will be randomised in a 1:1 ratio to either the active treatment group (Gynoclear™) or the placebo control.

Using Castor EDC’s randomisation function, a randomisation sequence using a block size of 6, with 1:1 group allocation, was performed on the 15th of January 2019 by NICMs Clinical Trial Manager who is external to this study. Randomisation numbers were allocated in permuted blocks of 6 containing 3 active and 3 placebo randomisation numbers. The investigator will allocate each randomisation number in order of number sequence starting with the lowest number in each block and using all numbers in a block of 6 before starting with the lowest number in the next block of numbers. As soon as the randomisation number is assigned, it will be recorded on the participant log, in the patient notes and case report form. Details of any patients randomised out of sequence will be notified immediately to the Chief Investigator.

Blinding

All study teams, participants and data analysts are blind to group allocation. Unblinding of participants to the study’s medical monitor, Dr Ee will be permitted if serious adverse events are reported.

Study interventions

Production of study supplement for the trial will be from one production batch lot and was manufactured according to Good Medical Practice guidelines. Study supplement dosing is six capsules (active or placebo) per day, taken three times daily, two capsules per time, preferably with food. The placebo matches Gynoclear™ (active) in colour, taste and smell. Table 2 outlines the composition of both the interventional product and placebo.

Table 2 Composition of interventional product (Gynoclear™) Full size table

Composition of placebo

Inactive placebo based on cellulose with a non-therapeutic input of cocoa powder (for colour matching).

Outcome measures and data capture

All data will be captured electronically via the secure electronic data capture platform Castor EDC [13]. Signed consent forms will be digitally captured and securely stored in Castor EDC.

Participants will not be required to physically attend any of the study visits for the trial, with the exception of two blood tests at certified pathology collection centre. The total study duration is 20 weeks: 4 weeks prior to trial entry to perform baseline pain screening diary, 12 weeks of active treatment and 4 weeks of follow-up. Six study visits/checkpoints will be required: (1) screening (confirm eligibility), (2) baseline (blood collection followed by dispensing medication), (3) week 6 phone call (check adverse events, compliance and medication use), (4) midpoint (week 12; check adverse events, compliance, medication use and dispense medication), (5) end of treatment (week 16; check adverse events, compliance and medication use and blood collection) and (6) post-treatment follow-up (week 20; check adverse events and collect pain diary scores of 1 month).

All data will be securely held on the study team database, accessible only by authorised investigators for the purposes of monitoring. The final dataset will be accessible by the coordinating investigators and each locality will retain on-site access to digital copies of source documentations with paper copies stored in secure archives.

Any changes to the study protocol are provided to the Human Research Ethics Committee as per protocol, trial registries will be updated. A copy of the consent form is included as Supplementary File 1.

Clinical assessments and patient surveys will be completed using Castor clinical trials management software. All the pre-specified outcome measures are outlined in Table 3:

Table 3 Outcome measures Full size table

EPDD

Participants will have access to the EPDD v3 [12] via an online web form. After focus groups with over 40 women with endometriosis, they identified that their top three symptom priorities were pelvic pain, fatigue and dyspareunia. The EPDD v3 already tracks pelvic pain and dyspareunia so modifications were made to include a daily fatigue score (0–10) in the same format.

Participant expectation and satisfaction questionnaires

At trial entry, participants will be asked about their current symptoms, and what expectations they have regarding changes of pain and other symptoms during the trial.

At the trial exit, participants will be asked to indicate which group they thought they were in, rate their satisfaction with the treatment given, what (if any) symptoms changed and what impact this had on them. Additional open-ended questions will explore acceptability including their experiences participating in the trial, likelihood of recommendation of the intervention to family and friends, interest in using the intervention again for pelvic pain symptoms, and feedback on the trial design and outcomes collected.

Health-related quality of life questionnaires

The Endometriosis Health Profile-30 (EHP-30) is an endometriosis specific health-related quality of life measure [14]. It covers pain, control and powerlessness, social support, emotional well-being and self-image. These 30 questions provide the core of the EHP-30. The EHP also includes optional secondary modules that may not be appropriate to all participants. If participants are currently working, they will be asked to fill in the ‘Work’ module, if they are currently in a sexual relationship, they will be asked to fill in the ‘Sexual relationship’ module. All measures have a 1 month recall and will be taken twice online; at baseline and at the end of the 4-week follow-up period.

The EQ-5D [15] and SF12 [16] are validated health-related outcome measures and provide the necessary data for economic analysis and have been recently used in our economic analysis of the impact of endometriosis in Australia [17]. The EQ-5D is administered via Castor EDC and the SF-12 will be administered via paper-based methods due to cost, at baseline and at the end of the 4-week follow-up period.

Fatigue severity scale (FSS)

The fatigue severity scale is a nine-item, seven-point questionnaire used to determine the impact of fatigue when performing daily activities [18]. This will be used as an adjunct to the numerical ratings given for daily fatigue, to provide a measure of the real-world impact of fatigue. This tool uses a seven-day recall. This will be administered online at baseline and at the end of the intervention.

Participant safety

The product has been listed as a listed medicine on the Australian Register of Therapeutic Goods (ARTG) (AUST L 197899). As the investigational product (Gynoclear™) is a low-risk product already approved by the Australian Therapeutic Goods Administration and available for purchase through health care practitioners. No adverse effects from oral consumption at the dosages outlined have been reported to the Australian Therapeutic Goods Administration. A formal data monitoring committee will not be established in Australia, however, the nominated medical representatives for the study, Dr Carolyn Ee, is a registered General Practitioner in Australia and will review safety on all adverse events.

Methods for adverse event recording and reporting include at all study visits beginning at the week 2 phone call and up until trial completion. Participants are also encouraged to report any safety concerns as soon as they become aware of it and have been provided with a written information sheet detailing the research team’s contact details (i.e. Clinical Trial Coordinator and Chief Investigator) for referral to the Dr Ee.

Safety markers in the blood will be tested at baseline and at trial exit. Participants will be asked to go to their local Laverty Pathology (or sister companies depending on region) collection centre. These safety tests will consist of the following markers in the blood: liver enzymes, bilirubin and albumin (liver function tests (LFTs)), urea and electrolytes (U&E) and red and white blood cells (full blood count). Electronic copies of blood test results will be sent to the medical representative of this study (Dr Carolyn Ee) for review when there are indications that blood markers are outside normal reference ranges.

Compliance

At each contact point (2-week phone call and midpoint call) compliance is checked verbally. At the midpoint, participants will be asked to return their three most empty trial product containers. These will be checked for compliance (75% or greater adhereance to the daily dose will be considered compliant) before the remaining trial product is dispensed. A similar procedure will occur at the end of treatment where participants are asked to return all remaining trial product.

Withdrawal

Participants who withdraw will have the reason for withdrawal (e.g adverse events, lack of efficacy) documented.

Concomitant medication

All participants are advised to continue taking their medications as per their doctors’ advice. Changes in concomitant medication are monitored via the study diaries.

Analysis plan

All data is captured via Castor EDC digitally, there are no paper instruments used in this trial. Data will be exported from Castor EDC into SPSS v24 (or greater). Prior to analysis, data will be cleaned by examining frequencies, means, medians, and ranges to identify logical errors. Instruments will be coded according to their respective scoring instructions. Unless specified by the instrument, missing items will be imputed based on averaging values within the instrument for a given individual, if no more than 15% of items are missing. Otherwise, that instrument will be set to missing for the individual.

Baseline demographics will be reported using descriptive statistics. Daily pain scores (as measured by the EPDD) will be converted into a single pain score at five time points, baseline, month 1, month 2, trial exit/end of intervention and follow-up. This single pain score will be achieved by taking the mean of the daily pain scores for the previous 4 weeks. Both a per-protocol and intention to treat analysis will be undertaken for the primary outcome of changes in pain scores. The same process of generating a single score will be used for the following outcomes: pain interference with activities of daily living (0–10), use of analgesics (number of days per month needing additional medication), severity of fatigue (0–10) and severity of dyspareunia (0–10). All scores will be analysed using repeated measures at baseline, month 1, month 2, trial exit and follow-up via a longitudinal linear mixed model analysis of variance with time and group as fixed effects and subject as a random effect.

Secondary outcomes of changes in EHP-30 scores, SF-12 scores and EQ-5D scores will be analysed using analysis of variance between baseline and one-month follow-up. FSS scores will be analysed using paired analysis of variance between baseline and the end of the intervention. Baseline values with be used as covariates in the analysis.

A cost-effectiveness (cost-utility) analysis will be conducted alongside the trial following international best practice [19]. This will assess the difference between trial arms in (i) costs—the cost of introducing modified GZFLW and the use of analgesic medications, measured using Medicare Benefits Scheme/Pharmaceutical Benefits Scheme, and (ii) effects—the difference in an economic measure of health-related quality of life, called the EQ-5D, which is used in estimating quality-adjusted life years. A cost-effectiveness analysis, combining i and ii, will then be conducted including subgroup analysis. Further, statistical uncertainty will be explored in a Probabilistic Sensitivity Analysis, health-related quality of life will be cross-validated using the SF12, and a Value of Information analysis will assess whether further research is required before making recommendations to mainstream modified GZFLW in routine practice.

Data monitoring and stopping guidelines

Data will be monitored by MaD and MA for completeness, plausibility and consistency to ensure the integrity and completeness of the data set. Any queries will be resolved by the Chief Investigator or delegated member of the study team. Adverse events will be regularly monitored via the online daily diary, as well as at each study visit conducted over the phone by the research team. Any serious adverse events will trigger an alert to the Chief Investigator and reporting to relevant authorities as per the National Health and Medical Research Council guidelines.

Study timeline

The expected duration of the data collection phase of this study will be 12 months, with 14 time points where data is collected. The schedule of enrolment, interventions and assessments as per SPIRIT [20] is outlined in Table 4.

Table 4 Timeline of treatment assessments and interventions Full size table

Dissemination of findings

A lay summary of the findings will be provided to all relevant endometriosis support and advocacy groups in Australia and via articles through organisations such as The Conversation. Dissemination through the academy will be via peer-reviewed publications in appropriate journals and at scientific conferences.

Data sharing plan

After the completion of the study, data will be made available to researchers upon review and approval of the submitted protocols by the research team. The full trial protocol is available via the principal investigator.

Guizhi Fuling Wan

Guizhi Fuling Wan (Chinese: 桂枝茯苓丸) is a brown pill used in Traditional Chinese medicine to “activate blood circulation, to remove blood stasis and mass in the abdomen”.[1] It is sweet in taste. It is used where there are symptoms such as “masses in the abdomen of women, amenorrhea due to blood stasis, menses with bellyache, or persistent lochia after delivery”. In clinical practice, medical scientists have discovered that Gui Zhi Fu Ling Wan can also treat some internal medical diseases and male diseases.[2] Honey is used as the binding agent, and each pill weighs about 6 grams.

History [ edit ]
Guizhi Fuling Wan has a history of more than 1,800 years, and its inventor is Zhang Zhongjing.

Chinese classic herbal formula [ edit ]
Name Chinese (S) Grams Ramulus Cinnamomi 桂枝 100 Poria 茯苓 100 Cortex Moutan 牡丹皮 100 Radix Paeoniae Rubra 赤芍 100 Semen Persicae 桃仁 100

See also [ edit ]

Gui Zhi Fu Ling Pian (Wan) (GyneAssure™)

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Top 33 Gui Zhi Fu Ling Wan 4879 Good Rating This Answer

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 | Trials | Full Text

Guizhi Fuling Wan – Wikipedia

Gui Zhi Fu Ling Pian (Wan) (GyneAssure™) | ActiveHerb

Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial – PubMed

The Multiple Pharmacologic Functions and Mechanisms of Action of Guizhi Fuling Formulation

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 –

Guizhi Fuling Wan

Gui Zhi Fu Ling Pian (Wan) (GyneAssure™)

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