Muco-bioadhesive Gel Containing Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis: A Randomized Clinical Study

Who is this study for? Patients with recurrent aphthous stomatitis
What treatments are being studied? Basil extract
Status: Unknown
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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% w/w PVA (Mw = 31-50 kDa, 98-99% hydrolysed) and 2% w/w 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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 40
Healthy Volunteers: t
View:

• age \> 18 years;

• a clear history of RAS (recurrent apthous stomatitis) occurring no less than four times a year;

• presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment;

• ulcers that took \> 5 days to resolve without treatment.

Locations
Other Locations
Egypt
Malak Yousef Mohamed Shoukheba
RECRUITING
Tanta
Contact Information
Primary
malak m shoukheba
smalakyousefmohamed@yahoo.com
+201012663927
Backup
malak m shoukheba
smalakyousefmohamed@yahoo.com
+20403335631
Time Frame
Start Date: 2021-01-01
Completion Date: 2021-12-01
Participants
Target number of participants: 30
Treatments
Experimental: basil extract mucoadhesive gel
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.
Placebo_comparator: mucoadhesive placebo gel
10 patients treated by mucoadhesive gel without drug which was used as placebo (contains tragacanth gum, alcohol, sodium benzoate, and distilled water) 4 times per day
Sham_comparator: healthy patients
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)
Authors
malak m shoukheba
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov