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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Oral Ulcer
• Intervention / Treatment: Drug: use of basil extract gel in treatment of aphthus ulcer; Other: muco adhesive placebo gel; Other: no treatment

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: malak m shoukheba; Phone Number: +201012663927; Email: smalakyousefmohamed@yahoo.com
• Study Contact Backup: Name: malak m shoukheba; Phone Number: +20403335631; Email: smalakyousefmohamed@yahoo.com

Study Locations

• Egypt
  • Tanta, Egypt, 20
    • Recruiting
    • Malak Yousef Mohamed Shoukheba
    • Contact: malak YM shoukheba; Email: smalakyousefmohamed@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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: anti inflammatory and immunomodulation effect of basil extract
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: placebo gel
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: negative control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
healing duration	patient evaluated by how long the ulcer takes to heal from baseline	one week
size of the ulcer	measuring the ulcer size at baseline,5 days, and one week	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	one week

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: malak YM shoukheba, Faculty of dentistry tanta university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Aphthous Stomatitis; basil extract; endocan marker
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Oral Ulcer; Stomatitis; Stomatitis, Aphthous; Anti-Inflammatory Agents
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No