Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis

NCT04734106 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB00069987
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety, as measured by the Change in the number and severity of adverse events (AE)

  Non-serious adverse events will be defined as any new medical condition or worsening of an existing medical condition, not to include the disease being studied. Severe adverse events will be defined as any adverse event that results in death, a life-threatening event, inpatient hospitalization, prolongation of existing hospitalization (hospitalization for an elective treatment of a pre-existing condition will not be considered a serious event), disability or incapacity, or an important medical event, which, though not included previously, may jeopardize the participant and may require medical or surgical intervention.

  Week 16

Secondary Outcomes (5)

• Change in Interstitial cystitis (IC)/bladder pain syndrome (BPS) symptoms, as measured by the O'Leary Sant Questionnaire

  Baseline, Weeks 4, 8, 12, and 16

• Change in Suprapubic Pain, as measured by the Genitourinary Pain Index (GUPI) questionnaire

  Baseline, Weeks 4, 8, 12, and 16

• Change in Urinary Frequency, as measured by 24-Hour Voiding Diaries

  Baseline, Weeks 1, 2, 3, 4, 8, and 12

• Change in Sexual Functioning and Satisfaction, as measured by the Male and Female Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction Brief Profile

  Baseline, Weeks 4, 8, 12, and 16

• Change in Perceived Quality of Life, as measured by the McGill Quality of Life questionnaire

  Baseline and Week 16

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Desert Harvest Aloe Vera Capsules

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo Capsules

Interventions

Desert Harvest Aloe Vera Capsules DRUG

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

Also known as: Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera

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

Placebo Capsules OTHER

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

Also known as: Avicel

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Desert Harvest: collaborator

Study Sites (1)

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial; Nocturia; Urinary Incontinence

Interventions

Cellulose

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stephen Walker, PhD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Walker, PhD

CONTACT

3367137272; swalker@wakehealth.edu

Kaylee A Ferrara, BS

CONTACT

336-713-1693; kferrara@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: February 18, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)