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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Oral Ulcer

Intervention / Treatment
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* Drug: use of basil extract gel in treatment of aphthus ulcer
* Other: muco adhesive placebo gel
* Other: no treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: basil extract mucoadhesive gel<br>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. | Drug: use of basil extract gel in treatment of aphthus ulcer<br>* This study aimed to evaluate the efficacy of basil extract (Ocimum basilicum) in the treatment of aphthous ulcers<br>* Other names: anti inflammatory and immunomodulation effect of basil extract;|
| Placebo Comparator: mucoadhesive placebo gel<br>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 | Other: muco adhesive placebo gel<br>* mucoadhesive gel without drug which was used as placebo (contains tragacanth gum, alcohol, sodium benzoate, and distilled water) 4 times per day<br>* Other names: placebo gel;|
| Sham Comparator: healthy patients<br>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) | Other: no treatment<br>* (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.<br>* Other names: negative control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score VAS (Visual Analogue Scale) | 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. | one week | 
| healing duration | patient evaluated by how long the ulcer takes to heal from baseline | one week | 
| size of the ulcer | measuring the ulcer size at baseline,5 days, and one week | one week | 
| salivary endocan level | 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 | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphthous Stomatitis, basil extract, endocan marker