Actively Recruiting
A Double-Blind, Placebo-Controlled Study to Establish the Safety and Efficacy of Super-Concentrated, Freeze-Dried 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
13 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
Researchers are evaluating the safety and effectiveness of super-concentrated, freeze-dried aloe vera capsules to manage symptoms of interstitial cystitis, a condition causing bladder pain and urinary frequency. This early phase 1, double-blind, placebo-controlled study aims to compare aloe vera capsules with placebo capsules to better understand their impact on symptom relief and safety. Participants will be randomly assigned to take either aloe vera capsules or matching placebo capsules over sixteen weeks. The aloe vera group will follow a dosing schedule that increases from 3 capsules twice daily in the first month to 4 capsules three times daily in the third month, followed by a gradual dose reduction during the fourth month. Placebo participants will follow the same dosing pattern with visually identical capsules. Participants must maintain at least 6 capsules per day during the first three months to remain in the study. During the trial, participants will self-administer capsules and complete several assessments, including symptom questionnaires, pain scales, urinary frequency diaries, sexual function surveys, and quality of life measures at multiple time points. Researchers will monitor safety by tracking adverse events and evaluating changes in symptom severity and quality of life. The total participation duration is sixteen weeks, with evaluations at baseline and at scheduled intervals throughout the study.
CONDITIONS
Brief 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 such as oral or injectable preparations, double barrier, vasectomized partner, or abstinence
- Participant must sign and date the informed consent
- Participant must report urinary frequency of at least 11 times per 24-hour day on average over the previous four weeks
- Participant must report pain or discomfort score of 4 or greater on a 0-9 Likert scale
- Urinary frequency and pain/discomfort symptoms must have been present for at least the previous 24 weeks before baseline screening
- Participants must report at least one voided volume greater than or equal to 75cc in a 24-hour period at baseline voiding diary
You will not qualify if you...
- Known allergy or intolerance to aloe vera in any form
- History of bladder tumors (malignant or benign)
- Current active bladder or urethral stones
- History of urethral cancer within the past five years
- Any unstable or severe medical condition affecting study outcome, including coronary artery disease, azotemia, or moderate to severe liver failure
- Previous treatment with cyclophosphamide (Cytoxan)
- History of cyclophosphamide or chemical cystitis, tuberculosis, or radiation cystitis
- History of pelvic radiation, bladder cancer or cancer in situ, or urethral cancer
- History of other active cancers requiring systemic treatment
- History of urethral diverticulum
- Inability to urinate spontaneously
- Symptoms improved by current therapy regimen
- Uncontrolled diabetes mellitus
- Previous participation in an aloe vera study
- Previous use of Desert Harvest aloe vera capsules
- Imminent change in residence that could affect compliance
- Unlikely to comply due to unmanaged medical or psychological issues such as dementia or speech/language deficits
- Substance abuse or dependency in past two years without treatment
- Male-specific: history of prostate cancer in past five years or prostatic infection in past three months
- Female-specific: history of uterine, cervical, or vaginal cancer in past five years
- Female-specific: currently pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants self-administer either aloe vera capsules or placebo capsules orally over a sixteen week period with a gradually increasing and then decreasing dosing regimen.
Visits at Baseline, Weeks 1, 2, 3, 4, 8, 12, and 16 for assessments
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
K
Kaylee A Ferrara, BS
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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