Aloe vera concentrate put to the test against chronic bladder pain
NCT ID NCT04734106
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This study tests whether a super-concentrated, freeze-dried aloe vera capsule can safely reduce symptoms of interstitial cystitis, a chronic bladder condition causing pain and frequent urination. About 30 adults with frequent urination and moderate-to-severe pain will receive either the aloe vera supplement or a placebo for several weeks. Researchers will track side effects and changes in bladder symptoms using standard questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- super-concentrated, freeze-dried aloe vera capsules
- What this could lead to
- If it works, this could offer a natural option for managing the pain and urinary urgency of interstitial cystitis.
- What could go wrong
- This is a very early, small trial, so results may not apply widely. Aloe vera supplements can cause digestive upset in some people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wake Forest Baptist Hospital
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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