A Phase 2 interventional study of use of basil extract gel in treatment of aphthus ulcer and muco adhesive placebo gel in Oral Ulcer, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Tanta University · Phase 2, Interventional, and Treatment
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)
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)
54 studies on the registry are indexed under Oral Ulcer; 11 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 47 interventional studies indexed under Oral Ulcer.
Browse Oral Ulcer studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
This study aimed to evaluate the efficacy of basil extract (Ocimum basilicum) in the treatment of aphthous ulcers
Also known as: anti inflammatory and immunomodulation effect of basil extract
mucoadhesive gel without drug which was used as placebo (contains tragacanth gum, alcohol, sodium benzoate, and distilled water) 4 times per day
Also known as: placebo gel
(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.
Also known as: negative control
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".
Time frame: one week
healing duration
patient evaluated by how long the ulcer takes to heal from baseline
Time frame: one week
size of the ulcer
measuring the ulcer size at baseline,5 days, and one week
Time frame: 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
Time frame: one week
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in May 2021, 4 months.
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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