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Herbal Supplement

Aloe Vera Capsules for Interstitial Cystitis

Phase < 1
Waitlist Available
Led By Stephen Walker, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must report in the baseline voiding diary at least one voided volume greater than or equal to 75cc in a 24-hour period.
Participant must report a urinary frequency of at least 11 times per 24-hour day, on average over the previous four weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 1, 2, 3, 4, 8, and 12
Awards & highlights

Study Summary

This trial will test whether taking super-concentrated, freeze-dried aloe vera capsules can help treat interstitial cystitis, a condition that causes bladder pain.

Who is the study for?
This trial is for adults with frequent urinary issues and pain from interstitial cystitis, who've had symptoms for at least 24 weeks. Women must use birth control if able to have children. Participants can't join if they have a history of bladder or urethral cancer, current severe diseases, allergies to aloe vera, uncontrolled diabetes, substance abuse without treatment in the past two years, are pregnant or breastfeeding, or their symptoms improve with current treatments.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of super-concentrated freeze-dried aloe vera capsules compared to placebo capsules in managing interstitial cystitis symptoms.See study design
What are the potential side effects?
While not specified here, potential side effects may include digestive discomfort such as cramps or diarrhea due to aloe vera's laxative properties; allergic reactions could occur in those sensitive to aloe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can urinate more than 75cc at least once in a day.
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I go to the bathroom to urinate at least 11 times a day.
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My pain or discomfort level is 4 or higher on a scale of 0 to 9.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 1, 2, 3, 4, 8, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1, 2, 3, 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety, as measured by the Change in the number and severity of adverse events (AE)
Secondary outcome measures
Change in Interstitial cystitis (IC)/bladder pain syndrome (BPS) symptoms, as measured by the O'Leary Sant Questionnaire
Change in Perceived Quality of Life, as measured by the McGill Quality of Life questionnaire
Change in Sexual Functioning and Satisfaction, as measured by the Male and Female Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction Brief Profile
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera CapsulesExperimental Treatment1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,083 Total Patients Enrolled
6 Trials studying Interstitial Cystitis
162 Patients Enrolled for Interstitial Cystitis
Desert HarvestUNKNOWN
Stephen Walker, PhDPrincipal InvestigatorWake Forest Health Sciences
2 Previous Clinical Trials
30 Total Patients Enrolled
2 Trials studying Interstitial Cystitis
30 Patients Enrolled for Interstitial Cystitis

Media Library

Aloe Vera Capsules (Herbal Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04734106 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been approved to partake in this experiment?

"This research is no longer open for recruitment. It was first announced on January 1st, 2023 and updated most recently on November 28th of the same year. If you are interested in alternative studies, there are currently 38 clinical trials looking to enrol people with bladder pain syndrome as well as one trial involving Desert Harvest Aloe Vera Capsules that has openings available."

Answered by AI

What medical issues can Desert Harvest Aloe Vera Capsules typically be utilized to address?

"Desert Harvest Aloe Vera Capsules are typically taken to manage stasis dermatitis, but they have also shown effectiveness in treating nummular dermatitis, acne and intertrigo."

Answered by AI

Are there any vacant slots remaining in this trial for potential participants?

"According to the clinicaltrials.gov portal, this medical trial is not currently enrolling new candidates as it was last updated on November 28th 2022. Despite that fact, there are presently 38 other trials actively searching for participants right now."

Answered by AI

Could you provide details on the existing research that has been conducted utilizing Desert Harvest Aloe Vera Capsules?

"Currently, there is one clinical trial examining the efficacy of Desert Harvest Aloe Vera Capsules; this research project has not reached Phase 3 yet. The bulk of these studies are conducted in Winston-Salem, North carolina but other locations have initiated their own trials as well."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Wake Forest Baptist Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

What questions have other patients asked about this trial?

How often would I have to come to your location ?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
2024. "Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04734106.
All > Interstitial Cystitis
~67 spots leftby Aug 2024
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