Wake Forest University Health Sciences
The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.
After being informed about the study and potential risks, all participants who have provided written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 4:1 ratio to aloe vera (study group) or placebo (control group), respectively. The dosing regimen will be increased by 3 capsules every month for 3 months and then reduced by 2 capsules every week during the fourth month for both groups. Participants will remain in the study for sixteen week…
Inclusion Criteria: * Females or males, aged 18 years or older * Females of childbearing potential must agree to use acceptable methods of birth control. Acceptable methods are oral and injectable preparations, double barrier, vasectomized partner, or abstinence. * Participant must sign and date the informed consent. * Participant must report a urinary frequency of at least 11 times per 24-hour day, on average over the previous four weeks. * Participant must report a pain/discomfort score of 4 or greater on a 0-9 Likert scale. * These reported urinary symptoms of frequency and pain/discomfort…
600 mg pure, freeze-dried aloe vera super-concentrate with a minimum of 200 mg glycosaminoglycan per capsule.
550mg of Avicel microcrystalline cellulose per two-piece, hard-shelled gelatin capsule.
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