Clinical trial NCT04710888: Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis
Official title: Muco-bioadhesive Gel Containing Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Ulcer
Keywords: Aphthous Stomatitis
basil extract
endocan marker
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: pain score VAS (Visual Analogue Scale)
timeFrame: one week
measure: healing duration
timeFrame: one week
measure: size of the ulcer
timeFrame: one week
measure: salivary endocan level
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Malak Yousef Mohamed Shoukheba
Study officials:
affiliation: faculty of dentistry tanta university
name: malak YM shoukheba
role: PRINCIPAL_INVESTIGATOR
References: