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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-01

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)

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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)

Conditions

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Oral Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

use of basil extract gel in treatment of aphthus ulcer

Intervention Type DRUG

This study aimed to evaluate the efficacy of basil extract (Ocimum basilicum) in the treatment of aphthous ulcers

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

Group Type PLACEBO_COMPARATOR

muco adhesive placebo gel

Intervention Type OTHER

mucoadhesive gel without drug which was used as placebo (contains tragacanth gum, alcohol, sodium benzoate, and distilled water) 4 times per day

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)

Group Type SHAM_COMPARATOR

no treatment

Intervention Type OTHER

(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.

Interventions

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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

Intervention Type DRUG

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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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anti inflammatory and immunomodulation effect of basil extract placebo gel negative control

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes