Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710888
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2021-01-08
Brief Title:
Basil Extract Ocimum Basilicum in the Management of Recurrent Aphthous Stomatitis
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Muco-bioadhesive Gel Containing Basil Extract Ocimum Basilicum in the Management of Recurrent Aphthous Stomatitis A Randomized Clinical Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
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:
RCT
Brief Summary:
A randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control 10 patients treated with mucoadhesive gel containing 2 of basil extract 4 times per day test group for 20 min after every meal and before going to bed The other 10 patients treated by mucoadhesive gel without drug which was used as placebo composed from 6 ww PVA Mw 31-50 kDa 98-99 hydrolysed and 2 ww sodium tetraydroxy borate 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals negative control group
Detailed Description:
A randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control Inclusion criteria will be i age 18 years ii a clear history of RASrecurrent apthous stomatitisoccurring no less than four times a year iii presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment iv ulcers that took 5 days to resolve without treatment Individuals will excluded if they i had underlying systemic diseases or a history of immunologic disorders ii were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs 1 month before study commencement iii are smokers iv are pregnant v had a history of abusing drugs or alcohol vi could not provide written informed consent
10 patients treated with mucoadhesive gel containing 2 of basil extract 4 times per day test group for 20 min after every meal and before going to bed The other 10 patients treated by mucoadhesive gel without drug which was used as placebo composed from 6 ww PVA Mw 31-50 kDa 98-99 hydrolysed and 2 ww sodium tetraydroxy borate 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals negative control group
10 patients treated with mucoadhesive gel containing 2 of basil extract 4 times per day test group for 20 min after every meal and before going to bed The other 10 patients treated by mucoadhesive gel without drug which was used as placebo composed from 6 ww PVA Mw 31-50 kDa 98-99 hydrolysed and 2 ww sodium tetraydroxy borate 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals negative control group
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