Clinical study pending or the natural treatment and prevention of odor caused by bacterial vaginosis (BV). per sexual history and/ or has not been screened in the last 3 months. 50.9 Median Score for Ordinary Businesses. Balance Moisturizing Personal Wash is a gentle, pH-balancing cleanser with soothing botanical A secondary aim is to determine how well study subjects are able to adhere to the study protocol. Its very toxic if inhaled and is also quite corrosive. will be with either the PI or sub-investigator. The study confirmed the diagnosis of BV, there was active treatment with antibiotics, and there was only one ingredient, the. Supplemental information provided by Good Clean Love: The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. racemic 1% lactic acid, and is iso-osmolar with serum. This is due to the belief that the memory of the original substance remains. if the continued use of Flourish will prevent recurrence of BV over a 6 month period. a "Guide to Completing the BV Trial." to a historical recurrence risk7. range. be done in the office, the Nugent scoring will be done by Dr. Vonetta Edwards. Its important to point out that this study in the NEJM I just referenced in no way supports the use of Bio.pHresh. The Flourish regimen uses patented Bio-Match technology to cleanse, moisturize and restore pH-balance; promoting healthy vaginal conditions. In addition, this section recognizes business models that are designed to address specific community-oriented problems, such as poverty alleviation through fair trade sourcing or distribution via microenterprises, producer cooperative models, locally focused economic development, and formal charitable giving commitments. Over a 2 year period, women in one academic OB/GYN clinic, who are patients of the PI and years. range and keep the growth of BV associated bacteria at low levels. or BV is a common cause of vaginal discharge, irritation and odor and is associated with a disturbance in the vaginal microbiome. The PI or sub-investigator will monitor AEs and SAEs. proteins with bactericidal activity which help to maintain their dominance. It is, therefore, much less likely to alter the acid-base balance of the vagina, and therefore less likely to predispose to bacterial vaginosis. It will also assess the ability of subjects to comply with All rights reserved. If irritation occurs, discontinue use and seek medical advice. Normal vaginal flora is lactobacilli dominant. Premenopausal women between 18 and 52 who have been diagnosed with BV at least once within the past year will be invited to enroll.

In addition, this section recognizes products or services that are designed to address a particular social problem for or through its customers, such as health or educational products, arts and media products, serving underserved customers or clients, and services that improve the social impact of other businesses or organizations. Res Microbiol. Its very toxic if inhaled and is also quite corrosive. The active ingredient in Good Clean Loves Bio.pHresh Vaginal Homeopathic Suppositories are homeopathic. If the participant is found to have BV at one You cant compare a tested product with a single ingredient with an untested product with multiple other ingredients. All products will be started after the first visit and continue throughout the 6-month study. In all content, we clearly recommend that readers refer back to their healthcare practitioners for all health-related questions. trial. 2004;17 Suppl 1:16-25. Review. Add that with the money to be made in vaginal shame, plus the fact that recurrent BV is a complex condition and many women are desperate for solutions, and youve got a gold mine. Epub 2016 Jul 11. Review. Ideal for women who experience vaginal dryness due to: hormone fluctuations including birth control pills, post childbirth and menopause,medications that cause mucus membranes to dry including antihistamines, antidepressants, opioids / pelvic pain or pain with sex. It is, therefore, much less likely to It is presented as natural which sounds very appealing, but once you read what it is actually all about, it also makes no sense. each day of the study as well as a diary in which participants will record daily symptoms. Good Clean Love should not be given the benefit of the doubt that this suppository is safe for the vagina. *These statements have not been evaluated by the Food and Drug Administration. As this is an observational study, there is no control group. Cis women aged 18-52 History of at least one prior episode of BV in the past year. Good Clean Love is recommended by health professionals nationwide and was declared "among the safest products on the market"_ by research conducted at Johns Hopkins University. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient. Good Clean Love Restore pH Balancing & Moisturizing Vaginal Gel Made with Organic Ingredients - 2 fl oz, undefined out of 5 stars with undefined reviews. In addition, the concept that like treats like means that, for example, saliva from a rabid dog can be diluted and subsequently used as a remedy for children with anger issues. Study Sponsor (Sexual Health and Wellness Institute) Restore will be used every other day. 2015 Apr;73(3). A total of 40 patients directed. About 15-30% will About 15-30% will have a recurrence in 3 months7. Ruz FO, Pascual L, Giordano W, Barberis L. Bacteriocins and other bioactive substances of probiotic lactobacilli as biological weapons against Neisseria gonorrhoeae. Its important to point out that this study in the, I just referenced in no way supports the use of Bio.pHresh. Sepia Officinalis, which is juice or extract from a cuttlefish. The idea that probiotics, meaning live beneficial bacteria like those found in the vagina (such as lactobacillus crispatus, lactobacillus rhamnosus, and lactobacillus reuteri, etc), could be used to help with BV is an active area of research. If you have been using homeopathic remedies because you thought they were natural, and never really read into the details of what those little pills under your tongue are all about, you are not alone. is beechwood creosote. clinicians, and clinical experiences during the trial will be obtained by short in person Remember, Like treats like.. Sold in over 20,000 retail locations, Good Clean Love is proud to be the top-selling organic intimacy brand on the U.S. market. Finally, many so-called natural products are adulterated, so you are taking the word of a company that believes in homeopathy that their product contains what it claims and nothing else. times for the duration of the study. on the subject in 2009 concluded the following. alter the acid base balance of the vagina, and therefore less likely to predispose to BV. BV symptoms include vaginal odor, itching, discharge, and irritation and can greatly impact a womans health, quality of life, sexual relations, self-image, and well-being. Remember, Like treats like., The idea that probiotics, meaning live beneficial bacteria like those found in the vagina (such as, , etc), could be used to help with BV is an active area of research. Treatment of bacterial vaginosis. Nasioudis D, Linhares IM, Ledger WJ, Witkin SS. secretions of women with L. crispatus-dominated microbiota. 2017 Jan;124(1):61-69. doi: 10.1111/1471-0528.14209. I have no idea how a hazardous product created by high-temperature treatment of beechwood is like a vagina with bacterial vaginosis. BV has also been associated with an increased risk of preterm labor, STD acquisition, and vaginal cuff cellulitis after hysterectomy. of Flourish use. and maintaining a healthy vaginal microbiome by restoring the vaginal pH in to the acidic Normal vaginal flora is lactobacilli dominant.

BV is more than an annoyance, women with BV are at increased risk for acquiring HIV, gonorrhea, chlamydia, and genital herpes if exposed. Sponsor of the study, will not interact directly with participants but will have a staff I have no idea how a hazardous product created by high-temperature treatment of beechwood is like a vagina with bacterial vaginosis. The Flourish Vaginal Care System and BiopHresh Vaginal Homeopathic Suppository use the companys Bio-Match technology to maintain the optimal vaginal ecosystem by allowing healthy lactobacilli to flourish, which Good Clean Love noted can alleviate symptoms of bacterial vaginosis, as well as dryness, odor, discomfort and urinary tract issues., The BiopHresh Vaginal Homeopathic Suppository and Flourish Vaginal Care System launched this month online, with suggested retail prices of $14.99 and $29.99, respectively.

You cant compare a tested product with a single ingredient with an untested product with multiple other ingredients. Currently, there are many sexual lubricants and vaginal moisturizers available on the market. doi: 10.1093/femspd/ftv013. No study has shown homeopathy works for any condition and the principle of dilution is not consistent with the laws of chemistry and physics. This system is comprised of a vaginal wash (Balance), an intravaginal moisturizing gel (Restore), and a vaginal probiotic supplement (BiopHresh). *HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States. Data from the participants' diaries and data Evolving the B Corp Certification Requirements, Multinationals & Large Enterprise Businesses. same procedures and also have a vaginal swab done for analysis by the Juno Vaginal Microbiome Homeopathy rests on the principle that like treats like and less is more. The theory is that the active ingredient in any homeopathic treatment is diluted so much that the few molecules remaining (that is if any remain) are more potent than the original. For newsletter communications relating to your local region, please visit Global Partner sites to subscribe. Content on this site is for reference purposes only. Research has shown as many as 30% Nasioudis, D., Linhares, I. M., Ledger, W. J., & Witkin, S. S. (2017). The first aim of this study is to determine if Flourish Vaginal Care System is able to reduce the vaginal pH to a health level (pH 3.5-4.2) in order to support a healthier vaginal microbiome. characterized by a shift in vaginal flora from an acidic environment due to acid producing Apply every third day, as a Bio-Matched blend of the leading strains of lactobacillus found in the healthiest vaginal tracts combined with homeopathic remedies for BV relief. Homeopathy rests on the principle that like treats like and less is more. The theory is that the active ingredient in any homeopathic treatment is diluted so much that the few molecules remaining (that is if any remain) are more potent than the original. Climacteric. On occasion, manufacturers may improve or change their product formulas and update their labels. In three easy steps, the Flourish regimen promotes good hygiene, helps restore healthy pH-levels, and delivers beneficial bacteria, including Lactobacillus Crispatus, to help reduce recurrence of symptoms. If subjects present with either When vaginal area is clean and dry insert the capsule using the provided applicator. If the subject chooses to participate after a thorough discussion of the risks and Please. A strict policy against plagiarism is maintained; all our content is unique, curated by our team of writers and editors at Fullscript. The It is postulated that lubricants and moisturizers may predispose to BV by altering the pH of Subjects will be will be enrolled; 20 in a shorter (12-week) preliminary study without microbiome analysis, The study may be prematurely terminated if it is determined that an abnormal number of Attribution to individual writers and editors is clearly stated in each article. , although you might be more familiar with its grown up name, . turn in a journal of daily product use and symptoms completed throughout the study. But probiotics are an active ingredient, that is why we are studying them to see if they can be helpful in preventing BV. If the item details above arent accurate or complete, we want to know about it. https://www.fda.gov/drugs/information-drug-class/homeopathic-products. Good Clean Love hosts an extensive sampling program that has provided over 250,000 samples to doctors, nurses, midwives, OB/GYN practitioners, and sexual health educators. Good Clean Love should not be given the benefit of the doubt that this suppository is safe for the vagina. Potential conflicts of interest are clearly disclosed. Allsworth JE, Peipert JF. Apparently its a remedy for offensive discharges., , which is juice or extract from a cuttlefish. 18 Years BV has also been associated We recommend that you do not rely solely on the information presented on our Web or Mobile sites and that you review the product's label or contact the manufacturer directly if you have specific product concerns or questions. In the United States, the National Health and Nutrition Examination Survey (NHANES), estimated the prevalence of BV was 29% in the general population of women aged 14 to 49 years and 50% in African-American women. extracts, formulated with more than 60% premium aloe. Topics include diversity, equity, and inclusion; economic impact; civic engagement; charitable giving; and supply chain management. hyperosmolar lubricants can be damaging to the epithelium and may alter the pH of the vagina. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Keeps me hopeful that one day my recurrent BV will disappear. Women with bacterial vaginosis received standard antibiotic therapy and then were randomized to the vaginal probiotic lactobacillus crispatus or placebo. Larsson P. G. (1992). the protocol. Then there are other factors, such as the ecosystem is dynamic andwe dont even really know what we should be replacing. Rinse well. and 20 in a longer (6-month) study including microbiome analysis. It is made without toxic saponifiers found in most bar soaps and OTC cleansers. BV symptoms include vaginal odor, itching, discharge, and irritation and can greatly impact a womans health, quality of life, sexual relations, self-image, and well-being. Pioneering in the sexual health industry with organic solutions, Good Clean Love is responsible for innovations such as Bio-Match technology and the first water-based lubricant with organic hemp oil, CBD CaraGold Premium Personal Lubricant. There are no clinical trials of this product, meaning there is zero data to support these assertions. Inactive ingredients typically means inert ingredients the stuff brought along for the ride so the active ingredients stay active and are dispersed in a way that they reach their target tissues. benefits, she will sign the informed consent and be enrolled in the trial. triggering by sensitive questions or procedures. Dermatol Ther. reported by their physician/clinician. will be responsible for making this determination. They will be followed longitudinally for six months. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Exploring the universe of clinical trials just got cosmically easier. BIOPHRESH HOMEOPATHIC VAGINAL SUPPOSITORYActive Ingredients Per Dose (purpose):Kreosotum 6C HPUS; Nitricum Acidum 6C HPUS(vaginal itching and irritation); Thuja Occidentalis 6C HPUS*; Pulsatilla Vulgaris 6C HPUS* (vaginal odor); Sepia Officinalis 6C HPUS* (vaginal discharge). Resources for patients are intended to be educational and do not replace the relationship between health practitioners and patients. It is characterized by a shift in vaginal flora from an acidic environment due to acid-producing lactobacilli to a mixture of anaerobic and facultative microorganisms. In the United States, the National Health and Nutrition Even though there is a lot of research in this area, BV remains poorly understood. So not a knock out of the park, but perhaps a piece of the puzzle. We will exclude vulnerable populations: adults unable to consent, individuals too young to consent, prisoners, and pregnant women. This study is designed to be a pilot/feasibility study. Homeopathy not only doesnt make scientific sense, it doesnt even make common sense. It is made without toxic saponifiers The study confirmed the diagnosis of BV, there was active treatment with antibiotics, and there was only one ingredient, the lactobacillus crispatus. Pulsatilla Vulgaris, a flower which is apparently good for almost everything from car sickness, to shifting leg pain, to PMS. $16.00, Regular price The aim of this study is to determine if Flourish Vaginal Care System aids in re-establishing screened as per the providers' discretion for GC/ CH and trichomonas if it seems indicated Copyright 2022, The Truth Beauty Company. At 12 weeks the rate of recurrence for BV was 30% in the probiotic group and 45% in placebo. After treatment with antibiotics, recurrences are common. Good Clean Love Bio-Match Restore pH Balanced Moisturizing Gel is formulated under the guidance of independent scientific research and mimics the body's natural lubricating response, accurately Bio-Matching pH, salt balance, and lactobacilli of the healthiest vaginal conditions. (confirmed via medical records) who currently have BV diagnosed via wet mount and vaginal pH, There is no proof that Good Clean Loves Bio.pHresh Vaginal Homeopathic Suppositories can help, and frankly, anything that is homeopathic is based on a scam. Yes, juice of cuttlefish is used to treat your vagina. You can read all about its toxicity here at the US Department of Health and Human Services Public Health Service Agency for Toxic Substances and Disease Registry. Get it, because rabid dogs are angry, their saliva can be used to treat anger. Subjects will be tested every 3 months, or more frequently if symptoms of BV or yeast infection develop. Unfortunately, so far the results have been underwhelming. $42.00. Ananthapadmanabhan, K. P., Moore, D. J., Subramanyan, K., Misra, M., & Meyer, F. (2004). This is a one-time sample collection and analysis at the end of the study. The underlying issue with BV appears to be a problem with the vaginal microbiome, meaning the vaginal bacteria are not reducing the pH sufficiently and/or producing enough of the substances that keep harmful bacteria in check. A clinical trial to investigate Restore Moisturizing Vaginal Gel for short-term resolution of BV will launch 2017. New Hampshire, I no longer recommend them given the low quality of available data, the lack of improvement that Ive seen with these products, and the cost some of them are $30-60 a month. Make sure the applicator is clean and dry before reusing. benefit corporation) or corporate governing documents. the only Sponsor staff that will have access to patient information including patient names Balance Moisturizing Personal Wash is a gentle, pH-balancing cleanser with soothing botanical extracts, formulated with more than 60% premium aloe. 0 subscriptions will be displayed on your profile (edit).

[6 months], Study Director: Wendy Strgar, Sexual Health & Wellness Institute, Concord, I am not making this up. Bacterial vaginosis or BV is a common cause of vaginal discharge, irritation and odor and is associated with a disturbance in the vaginal microbiome. Information about supplements is always based on ingredients. When I mentioned I would be taking questions for a weekly column, several people asked about Good Clean Loves Vaginal Suppositories. It is formulated to bio-match the vaginal Transforming the global economy to benefit all people, communities, and the planet. All content is updated on a regular basis to account for new research and industry trends, and the last update date is listed at the top of every article. But hey, Im willing to learn. Subjects will be tested every 3 months, or more frequently if symptoms of BV or yeast infection develop. They will also be interviewed to obtain clinical experiences during the trial and will Click the link we sent to , or click here to sign in. BV has also been associated with an increased risk of preterm labor, STD acquisition, and vaginal cuff cellulitis after hysterectomy6.

Thanks for sharing. member in the role of "Physician Liaison" available to assist physicians/clinicians at all Obstet Gynecol. This is a booklet containing detailed instructions for Based on the B Impact assessment, Good Clean Love earned an overall score of 88.8. While BV responds well to antibiotic therapy, there is a high recurrence rate up to one-third of women with BV can have a recurrence in 3 months and by 12 months that number rises to about 50%. Recommended for daily use. at the US Department of Health and Human Services Public Health Service Agency for Toxic Substances and Disease Registry. other strains found in the most stable vaginal microbiome. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition?. Use every third day. third aim is to determine what the vaginal microbiome community state type is after 6 months In order to provide unbiased and transparent education, information is based on a research review and obtained from trustworthy sources, such as peer-reviewed articles and government websites.

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