A Double-Blind, Placebo-Controlled Study to Establish the Safety and Efficacy of Super-Concentrated, Freeze-Dried Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
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.
• 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 must have been present for at least the previous 24 weeks prior to the first baseline screening visit.
• Participants must report in the baseline voiding diary at least one voided volume greater than or equal to 75cc in a 24-hour period.