NCT04734106 · Wake Forest University Health Sciences
Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
What this study is about
The purpose of this study is to assess the safety and effectiveness of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Winston-Salem, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2025 · Source of record for eligibility and locations