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

Who is this study for? Patients with Interstitial Cystitis
What treatments are being studied? Desert Harvest Aloe Vera Capsules
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Wake Forest Baptist Hospital
RECRUITING
Winston-salem
Contact Information
Primary
Stephen Walker, PhD
swalker@wakehealth.edu
3367137272
Backup
Kaylee A Ferrara, BS
kferrara@wakehealth.edu
336-713-1693
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2027-07
Participants
Target number of participants: 30
Treatments
Experimental: Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera Capsules
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.
Placebo_comparator: Placebo
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.
Related Therapeutic Areas
Sponsors
Collaborators: Desert Harvest
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov

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