FDA Greenlights Aloe Vera Study for Interstitial Cystitis |

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Wake Forest University has joined forces with Desert Harvest, our family-owned wellness brand renowned for its commitment to addressing women’s health issues through high-quality Aloe Vera and rigorous research. Our three-decade journey began when our research discovered, for the first time, the link between aloe vera and bladder pain. Now, we are on the brink of launching a study to assess the viability of our Super-Strength Aloe Vera Capsules as an FDA-approved drug for interstitial cystitis (IC) in 2024. If approved, our product becomes the first FDA-approved IC treatment alternative to pentosan polysulfate sodium and the first prescription IC therapy not developed by a pharmaceutical company.

Interstitial cystitis is a chronic bladder condition affecting 3 to 8 million women in the United States, causing pelvic pressure and pain. Although the exact cause remains elusive, irritation and inflammation of the bladder lining are believed to contribute, leading to heightened sensitivity in the nerves of the bladder lining. Primarily affecting women in their 50s, hormonal changes, especially those linked to menopause, may influence symptom development or exacerbation. IC resembles a urinary tract infection (UTI) but lacks a sudden onset or resolution. Unlike UTI symptoms that typically clear with antibiotics, IC symptoms can persist for months, years, or indefinitely.

Our company’s roots date back to the early ’90s when my aunt grappled with Interstitial Cystitis, navigating through various misdiagnoses. A turning point came when she found momentary relief through aloe vera capsules introduced at a conference. However, due to the low quality of the aloe vera, she had to consume an entire bottle for relief. Recognizing the potential of aloe as a solution, our team delved into research, focusing on elevating aloe vera’s potency and its connection to bladder health. This collaborative effort resulted in the development of our Super-Strength Aloe Vera Capsules, with our 1995 study substantiating their efficacy by revealing an impressive 87.5% of participants experiencing substantial relief.

For individuals grappling with interstitial cystitis (IC), the landscape of available options has been narrow, primarily hinging on Elmiron, a product crafted by Janssen Pharmaceuticals and the exclusive FDA-approved medication. Sadly, Elmiron has become embroiled in a cascade of class-action lawsuits since 2020, raising alarming concerns about prolonged usage and its potential to induce severe eye-tissue damage, including pigmentary maculopathy, retinal maculopathy, or macular degeneration. Amidst the current uncertainties, our collaboration with the Wake Forest University endeavors to provide a secure alternative for patients facing these challenges.

Approval not only ensures a safer option but also introduces a more affordable alternative. Although doctors can currently recommend our Super-Strength Aloe Vera Capsules as an IC treatment plan, the majority of insurance companies refrain from covering the cost without FDA approval. Priced at $68 per bottle, some patients face challenges affording our aloe capsules without insurance coverage. While we do extend assistance to those unable to meet the retail cost, we anticipate FDA approval will enable patients reliant on insurance to access our product through prescription coverage.

Scheduled to commence in January 2024, the FDA study is set to be a year-long exploration, starting with a cohort of 30 patients, focusing on safety and efficacy assessments before broadening its scope. The study will measure changes in IC symptoms, suprapubic pain, urinary frequency, sexual functioning and satisfaction, and perceived quality of life. A portion of the study also will examine the impact of increasing and decreasing dosage. This study builds on four preceding investigations conducted on our aloe for interstitial cystitis (IC). In 1995, a study with The Urology Wellness Center reported 87.5% experiencing relief, with 50% achieving significant relief. In 2002, Dr. Kristene E. Whitmore endorsed Desert Harvest’s aloe for managing IC symptoms in her study on alternative therapies for Interstitial Cystitis. A 2016 survey with the Interstitial Cystitis Association showed 92% experiencing relief, with notable improvements in urination and pelvic pain. In 2021, a study in Italy with Dr. Mauro Cervigni just completed and the data will be published in early 2024. Both ongoing and prior studies demonstrate Desert Harvest’s Super-Strength Aloe Vera capsules outperform other available therapies for IC.

Our success is rooted in an unwavering dedication to a meticulous harvesting process, a critical aspect of producing potent and bladder-safe aloe vera. Unlike the majority of aloe products on the market, our exclusive method incorporates volcanic soil cultivation, precise on-site harvesting within a 20-minute window, and thorough processing of the entire aloe vera leaf to eliminate potential carcinogenic effects. Our patented process stands as the only proprietary method capable of completely removing anthraquinones, known bladder irritants with long-term dangers. A significant misunderstanding arising from our research is the misconception that all aloe capsules or juices are safe for individuals with interstitial cystitis, which is untrue. Many other aloe capsules and juices on the market contain harmful components and preservatives that can trigger detrimental flares in people suffering from IC. Juices may also undergo pasteurization, depleting active nutrients and leaving behind essentially expensive water, considering aloe vera is 95% water.

In closing, our journey at Desert Harvest is propelled by a steadfast commitment to advancing women’s health through pioneering research and high-quality Aloe Vera solutions. The FDA’s approval of our groundbreaking study for Interstitial Cystitis represents a significant milestone, offering hope for those grappling with this chronic bladder condition. With a legacy rooted in compassion and a relentless pursuit of excellence, we stand on the precipice of transforming the treatment landscape. As we embark on this pivotal year-long exploration, our Super-Strength Aloe Vera Capsules remain at the forefront, meticulously crafted to address the complexities of IC. We express gratitude for the unwavering support from the medical community, our dedicated team, and the individuals who inspire our mission. Together, we look ahead to a future where accessible, safe, and effective alternatives redefine the path to wellness for all.Top of Form

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