NCT04734106

Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After being informed about the study and potential risks, all participants who have provided written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 4:1 ratio to aloe vera (study group) or placebo (control group), respectively. The dosing regimen will be increased by 3 capsules every month for 3 months and then reduced by 2 capsules every week during the fourth month for both groups. Participants will remain in the study for sixteen weeks.

Conditions

• Interstitial Cystitis
• Chronic Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DRUG	Desert Harvest Aloe Vera Capsules	600 mg pure, freeze-dried aloe vera super-concentrate with a minimum of 200 mg glycosaminoglycan per capsule.
OTHER	Placebo Capsules	550mg of Avicel microcrystalline cellulose per two-piece, hard-shelled gelatin capsule.

Timeline

• Start date: 2025-02-18
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2021-02-02
• Last updated: 2025-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study