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

Oral Ulcer Clinical Trial

— RCT  

Official title:

Muco-bioadhesive Gel Containing Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis: A Randomized Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04710888
• Other study ID #: 3
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2021
• Source: Tanta University
• Contact: malak m shoukheba
• Phone: +201012663927
• Email: smalakyousefmohamed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Ulcer
• Stomatitis
• Stomatitis, Aphthous

Intervention

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:
• 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
• 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.

Locations

Country	Name	City	State
Egypt	Malak Yousef Mohamed Shoukheba	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	one week
Primary	healing duration	patient evaluated by how long the ulcer takes to heal from baseline	one week
Primary	size of the ulcer	measuring the ulcer size at baseline,5 days, and one week	one week
Primary	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	one week