RCT: Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: basil extract mucoadhesive gel 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
This study aimed to evaluate the efficacy of basil extract (Ocimum basilicum) in the treatment of aphthous ulcers
Other Names:
|
| Placebo Comparator: mucoadhesive 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 |
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 Names:
|
| Sham Comparator: healthy patients 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
(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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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".
- healing duration [one week]
patient evaluated by how long the ulcer takes to heal from baseline
- size of the ulcer [one week]
measuring the ulcer size at baseline,5 days, and one week
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Malak Yousef Mohamed Shoukheba | Tanta | Egypt | 20 |
Sponsors and Collaborators
- Tanta University
Investigators
- Principal Investigator: malak YM shoukheba, faculty of dentistry tanta university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3