Recruiting
Early Phase 1

Aloe Vera

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04734106

Conditions

Interstitial Cystitis

Chronic Interstitial Cystitis

Bladder Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Desert Harvest Aloe Vera Capsules

Placebo Capsules

Study Details

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.

Conditions

Interstitial Cystitis

Chronic Interstitial Cystitis

Bladder Pain Syndrome

Study ID

NCT04734106

Start date

Feb 18, 2025

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera Capsules

Participants will self-administer Desert Harvest super-concentrated, freeze-dried aloe vera capsules orally over a sixteen week period. The dosing regimen includes administering 3 capsules twice daily for the first month, 3 capsules three times daily for the second month, and 4 capsules three times daily for the third month. During the fourth month, participants will administer 10 capsules per day the first week (4 in the morning, 2 in the afternoon, and 4 in the evening), 8 capsules per day the second week (4 in the morning, 4 in the evening), 6 capsules per day the third week (3 in the morning, 3 in the evening), and 4 capsules per day the fourth week (2 in the morning, 2 in the evening). A participant must stay on a minimum of 6 capsules per day for the first three months in order to remain in the study.

placebo comparator: Placebo

Participants will self-administer placebo capsules orally, matching the dosing regimen of the experimental treatment, over a sixteen week period. Placebo capsules will be identical in appearance and packaging to the experimental capsules.

Interventions

Desert Harvest Aloe Vera Capsules

600 mg pure, freeze-dried aloe vera super-concentrate with a minimum of 200 mg glycosaminoglycan per capsule.

Placebo Capsules

550mg of Avicel microcrystalline cellulose per two-piece, hard-shelled gelatin capsule.

Primary outcome measure

  • Safety, as measured by the Change in the number and severity of adverse events (AE) [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Stephen Walker, PhD

3367137272Stephen.J.Walker@advocatehealth.org

Kaylee A Ferrara, MA

336-713-1693Kaylee.Ferrara@advocatehealth.org

Locations

Wake Forest Baptist Hospital

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Kaylee A Ferrara, BS

336-713-1693Kaylee.Ferrara@advocatehealth.org

Principal Investigator:

Stephen Walker, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Interstitial Cystitis (IC)
  • Bladder Pain Syndrome
  • Urinary urgency
  • Urinary frequency
  • Bladder pain
  • Nocturia
  • Urinary incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-28.