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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04734106
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Bladder Pain Syndrome
  • Chronic Interstitial Cystitis
  • Interstitial Cystitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 18, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Safety, as measured by the Change in the number and severity of adverse events (AE) [ Time Frame: Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist HospitalWinston-SalemNorth Carolina27157
Kaylee A Ferrara, BS
[email protected]
336-713-1693
Stephen Walker, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Wake Forest Baptist Hospital· Winston-Salem, NC

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