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

NCT ID: NCT04734106

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2027-07-31

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.

Detailed Description

After being informed about the study and potential risks, all participants who have provided written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 4:1 ratio to aloe vera (study group) or placebo (control group), respectively. The dosing regimen will be increased by 3 capsules every month for 3 months and then reduced by 2 capsules every week during the fourth month for both groups. Participants will remain in the study for sixteen weeks.

Conditions

Interstitial Cystitis; Chronic Interstitial Cystitis; Bladder Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Desert Harvest Aloe Vera Capsules

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Capsules

Intervention Type: OTHER

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

Interventions

Desert Harvest Aloe Vera Capsules

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

Intervention Type: DRUG

Placebo Capsules

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

Intervention Type: OTHER

Other Intervention Names

Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera; Avicel

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.

• Males with a history of prostate cancer within the previous five years.
• Males with a prostatic infection within the previous three months.

• Females with a history of uterine, cervical, or vaginal cancer within the previous five years.
• Pregnant or lactating females.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Desert Harvest

UNKNOWN

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Walker, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Walker, PhD

Role: CONTACT

swalker@wakehealth.edu

3367137272

Kaylee A Ferrara, BS

Role: CONTACT

kferrara@wakehealth.edu

336-713-1693

Facility Contacts

Kaylee A Ferrara, BS

Role: primary

kferrara@wakehealth.edu

336-713-1693

Other Identifiers

IRB00069987

Identifier Type: -

Identifier Source: org_study_id