Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis (NCT04734106) | Clinical Trial Compass
RecruitingEarly Phase 1
Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
United States30 participantsStarted 2025-02-18
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 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.
Exclusion Criteria:
* Known allergy or intolerance to aloe vera in any form as reported by the participant or derived from medical records.
* History of Bladder tumors (malignant or benign).
* Current active bladder or urethral calculus.
* History of urethral cancer within the previous five years.
* Any disease which, in the opinion of the investigator, may be unstable or have bearing on the outcome of the study, including severe debilitating concurrent medical conditions such as coronary artery disease, azotemia, moderate to severe hepatic insufficiency, etc.
* Previous treatment with Cytoxan (cyclophosphamide).
* History of cyclophosphamide or chemi…
What they're measuring
1
Safety, as measured by the Change in the number and severity of adverse events (AE)