NCT04734106 Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
| NCT ID | NCT04734106 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Interstitial Cystitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-02-18 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Stephen Walker, PhD
PRINCIPAL INVESTIGATOR
Wake Forest Health Sciences
Frequently Asked Questions
Who can join the NCT04734106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Interstitial Cystitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04734106 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04734106 currently recruiting?
Yes, NCT04734106 is actively recruiting participants. Contact the research team at swalker@wakehealth.edu for enrollment information.
Where is the NCT04734106 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT04734106 clinical trial?
NCT04734106 is sponsored by Wake Forest University Health Sciences. The principal investigator is Stephen Walker, PhD at Wake Forest Health Sciences. The trial plans to enroll 30 participants.