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

Phase 2

• Conditions: Oral Ulcer
• Interventions: Drug: use of basil extract gel in treatment of aphthus ulcer; Other: muco adhesive placebo gel; Other: no treatment

• Registration Number: NCT04710888
• Lead Sponsor: Tanta University

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% 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)

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-15
• Primary Completion: 2021-05-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-14
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• had underlying systemic disease(s) or a history of immunologic disorder(s);
• were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs < 1 month before study commencement;
• are smokers;
• are pregnant;
• had a history of abusing drugs or alcohol;
• could not provide written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
basil extract mucoadhesive gel	use of basil extract gel in treatment of aphthus ulcer	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.
mucoadhesive placebo gel	muco adhesive 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
healthy patients	no treatment	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)

Primary Outcome Measures

Name	Time	Method
pain score VAS (Visual Analogue Scale)	one week	The patients will be asked to record the daily level of pain severity of the ulcers through VAS (Visual Analogue Scale). It consisted of a 10-cm horizontal line, and the end of the line is (0) indicating "no pain" and the other end is (10) denoting "unbearable pain".
salivary endocan level	one week	enzyme-linked immunosorbent assays to measure the salivary concentrations of endocan marker at the first visit (i.e., before treatment) and the other was just after healing
size of the ulcer	one week	measuring the ulcer size at baseline,5 days, and one week
healing duration	one week	patient evaluated by how long the ulcer takes to heal from baseline

Trial Locations

Locations (1)

Malak Yousef Mohamed Shoukheba; 🇪🇬 Tanta, Egypt