Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734106
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2021-01-27
Brief Title:
Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 41 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None