Actively Recruiting
Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
Led by Wake Forest University Health Sciences · Updated on 2025-08-27
30
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
D
Desert Harvest
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females or males, aged 18 years or older
- Females of childbearing potential must agree to use acceptable birth control methods
- Participant must sign and date the informed consent
- Urinary frequency of at least 11 times per 24-hour day on average over the previous four weeks
- Pain or discomfort score of 4 or greater on a 0-9 Likert scale
- Symptoms of urinary frequency and pain/discomfort present for at least 24 weeks prior to screening
- At least one voided volume of 75cc or greater recorded in baseline voiding diary
You will not qualify if you...
- Known allergy or intolerance to aloe vera
- History of bladder tumors (malignant or benign)
- Current active bladder or urethral stones
- History of urethral cancer within the previous five years
- Unstable or severe medical conditions that may affect study outcome
- Prior treatment with Cytoxan (cyclophosphamide)
- History of cyclophosphamide or chemical cystitis, tuberculosis, or radiation cystitis
- History of pelvic radiation, bladder cancer or cancer in situ, or urethral cancer
- Current neoplastic disease requiring systemic nonprophylactic treatment
- History of urethral diverticulum
- Inability to void spontaneously
- Symptoms relieved by current therapy
- Uncontrolled diabetes mellitus
- Previous enrollment in an aloe vera study
- Previous use of Desert Harvest aloe vera capsules
- Imminent residence change that could affect compliance
- Unlikely to comply due to unmanaged medical or psychological issues including dementia or aphasia
- Substance abuse or dependency in past two years without treatment
- Males with history of prostate cancer within five years
- Males with prostatic infection within past three months
- Females with history of uterine, cervical, or vaginal cancer within five years
- Pregnant or lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Stephen Walker, PhD
CONTACT
K
Kaylee A Ferrara, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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