RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-18

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04734106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Stephen Walker, PhD

CONTACT

3367137272

swalker@wakehealth.edu

Kaylee A Ferrara, BS

CONTACT

336-713-1693

kferrara@wakehealth.edu

Principal Investigator

Stephen Walker, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Study Locations (Sites)

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Stephen Walker, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-18

Study Completion Date2027-07

Study Record Updates

Study Start Date2025-02-18

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Interstitial Cystitis
Chronic Interstitial Cystitis
Bladder Pain Syndrome