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

Tanta University

Status and phase: Unknown; Phase 2

Conditions: Oral Ulcer

Treatments: Drug: use of basil extract gel in treatment of aphthus ulcer; Other: muco adhesive placebo gel; Other: no treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04710888

3

Details and patient eligibility

About

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)

Full 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)

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

basil extract mucoadhesive gel

Experimental group

Description:

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.

Treatment:

Drug: use of basil extract gel in treatment of aphthus ulcer

mucoadhesive placebo gel

Placebo Comparator group

Description:

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

Treatment:

Other: muco adhesive placebo gel

healthy patients

Sham Comparator group

Description:

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)

Treatment:

Other: no treatment