Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Feb 1, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of freeze-dried aloe vera capsules for people who suffer from interstitial cystitis, a condition that causes frequent and painful urination. Researchers want to see if these capsules can help manage the symptoms like pain and the urge to urinate. The study is currently recruiting participants aged 18 and older who have been experiencing these symptoms consistently for at least 24 weeks and have a certain level of pain and urinary frequency.

To be eligible, participants must agree to use birth control if they can become pregnant, and they should not have any known allergies to aloe vera or a history of certain bladder conditions. If you decide to participate, you will need to keep a diary of your urination for a day and report your experiences. This trial could be a chance to explore a new treatment option for managing interstitial cystitis symptoms, but it’s important to discuss with your doctor if you meet the criteria and if this study is right for you.

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Eligibility criteria

• 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 chemical cystitis or tuberculosis or radiation cystitis.
• • History of pelvic radiation treatment, bladder cancer or cancer in situ, or urethral cancer.
• • History of any other neoplastic process currently requiring systemic, nonprophylactic treatment.
• • History of urethral diverticulum.
• • Inability to void spontaneously.
• • Subjects with interstitial cystitis symptoms alleviated by current therapy regimen.
• • Uncontrolled diabetes mellitus.
• • Previous enrollment in an aloe vera study.
• • Previous use of Desert Harvest super-concentrated, freeze-dried aloe vera capsules.
• • Any imminent change in residence that could compromise compliance.
• • Unlikely to be compliant due to unmanaged medical or psychological problem, including dementia, aphasia, or other deficits of cognition or speech/language function that will interfere with the participant's ability to complete the study.
• • Substance abuse or dependency problem within the past two years for which patient received no treatment.
• Male-Specific Exclusion Criteria:
• • Males with a history of prostate cancer within the previous five years.
• • Males with a prostatic infection within the previous three months.
• Female-Specific Exclusion Criteria:
• • Females with a history of uterine, cervical, or vaginal cancer within the previous five years.
• • Pregnant or lactating females.