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

NCT04710888 | Unknown Phase 2 DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Oral Ulcer

Keywords

Aphthous Stomatitis; basil extract; endocan marker

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

basil extract mucoadhesive gel

EXPERIMENTAL

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

mucoadhesive placebo gel

PLACEBO COMPARATOR

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

healthy patients

SHAM COMPARATOR

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

Interventions

use of basil extract gel in treatment of aphthus ulcer DRUG

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

basil extract mucoadhesive gel

muco adhesive placebo gel OTHER

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

mucoadhesive placebo gel

no treatment 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.

Also known as: negative control

healthy patients

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Malak Yousef Mohamed Shoukheba

Tanta, 20, Egypt

RECRUITING

MeSH Terms

Conditions

Oral Ulcer; Stomatitis, Aphthous

Interventions

Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Stomatitis

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• malak YM shoukheba

  faculty of dentistry tanta university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

malak m shoukheba

CONTACT

+201012663927; smalakyousefmohamed@yahoo.com

malak m shoukheba

CONTACT

+20403335631; smalakyousefmohamed@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate prof.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 15, 2021
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)