Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06219018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-11
Brief Title:
Effect of Honey For CIN II
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
The Effect of Medical Grade Honey L-Mesitran for Cervical Intraepithelial Neoplasia-II
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
HoneyForCIN2
Brief Summary:
The following hypothesis is tested Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase inthe normalization of CIN II lesions compared to expectant management
Detailed Description:
In this pilot study we will include 60 patients with newly diagnosed CIN II Patients will be counseled according to standard guidelines between a LLETZ imiquimod or expectant management 1 Patients choosing for expectant management will be asked to participate in the study and treatment with medical grade honey Patients choosing imiquimod or LLETZ will be asked for the control arm Follow-up assessment takes place in accordance with the national guideline first check-up is after 6 months 1 In addition swabs for vaginal microbiota analysis will be taken at 0 and 6 months Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t0 This exploratory study assesses the potential effect of honey the optimal dosage and provides insight into its mechanisms of action
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None