NCT04710888

Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Accepted

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)

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 RAS(recurrent apthous stomatitis)occurring 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 disease(s) or a history of immunologic disorder(s); (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% 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)

Conditions

• Oral Ulcer

Interventions

Type	Name	Description
DRUG	use of basil extract gel in treatment of aphthus ulcer	This study aimed to evaluate the efficacy of basil extract (Ocimum basilicum) in the treatment of aphthous ulcers
OTHER	muco adhesive placebo gel	mucoadhesive gel without drug which was used as placebo (contains tragacanth gum, alcohol, sodium benzoate, and distilled water) 4 times per day
OTHER	no treatment	(i) had underlying systemic disease(s) or a history of immunologic disorder(s); (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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-05-01
• Completion: 2021-12-01
• First posted: 2021-01-15
• Last updated: 2021-07-14

Locations

1 site across 1 country: Egypt