超强芦荟和 FDA：您需要了解的信息
What is Aloe Vera’s role in treating IC?
Our Super-Strength Aloe Vera Capsules are currently sold as a nutritional supplement designed specifically to help people suffering from IC. Starting in 1995, we’ve conducted clinical trials for more than a quarter-century that has demonstrated that the product helps relieve IC symptoms such as pelvic pain, urethral burning, and urgency and frequency of urination in a large majority of patients. And while our capsules have been recommended by physicians who work with IC patients for many years, because of their status as a nutritional supplement, they can’t be prescribed as a drug.
What would FDA approval mean?
There’s currently only one medication approved by the FDA to treat IC symptoms—pentosan polysulfate sodium (Elmiron), which in recent years has been connected to vision problems in some patients and research has shown are only effective for some patients. If our Aloe Vera product is approved by the FDA, doctors would have an FDA-approved alternative to Elmiron they could prescribe to IC patients.
It also could be included in the official treatment guidelines for IC, which currently don’t reflect research involving any herbal or supplement treatments. As a result, more doctors would be aware of the benefits of Aloe Vera in treating IC symptoms, and more people suffering from IC could start using it right away as part of their treatment plan. While there are no uniformly effective treatments—or a cure—for IC/BPS, Aloe Vera could help reduce the pain and suffering of many more patients much earlier in their IC/BPS journeys. Our product would also be the first prescription IC/BPS therapy not developed by a pharmaceutical company.
Our proprietary super-concentrated extract is antibacterial, antifungal, antibiotic, analgesic, anesthetic, antiseptic, antiviral, antimicrobial, antifungal, and anti-inflammatory. Our patented process filters out anthraquinones—an irritant and carcinogen naturally found in Aloe Vera that can cause diarrhea— meaning there are no harsh side effects even during long-term use at its super-concentrated strength.
What will happen next?
In June, the FDA and the Wake Forest Institutional Review Board approved a double-blind, placebo-controlled Phase 1 clinical trial to further validate our product’s value for IC treatment. Conducted at Wake Forest Baptist Health at Wake Forest University in Winston-Salem, N.C., the six-month clinical trial will include 30 patients given a regimen of Desert Harvest Super-Strength Aloe Vera Capsules or a placebo.
It will measure changes in IC symptoms, suprapubic pain, urinary frequency, sexual functioning and satisfaction, and perceived quality of life, as well as the impact of increase and decreasing dosage. The study should be completed in 2022 and will be followed by a larger, multicenter Phase 2 trial with as many as 600 IC patients.
The results from these studies will be used as part of the FDA’s review process. We speak to customers every day who tell us that our product has helped them control months or years of debilitating pain and disruption to their daily routines. With FDA approval, our product could help many more patients live more normal lives.
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