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Aloe vera concentrate put to the test against chronic bladder pain

NCT ID NCT04734106

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

interstitial cystitis Nocturia Urinary Incontinence

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Wake Forest Baptist Hospital

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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