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Tests treatment safety and results for Interstitial Cystitis
Official title Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
ClinicalTrials.gov ID: NCT04734106
What this study is testing
What is Desert Harvest Aloe Vera Capsules?
Desert Harvest Aloe Vera Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for interstitial cystitis.
Also referred to as Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- 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.
You likely can't join 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...
- Previous treatment with Cytoxan (cyclophosphamide).
See the full eligibility 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...
- 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.
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.