Rheumatoid Arthritis
Conditions
Brief summary
The aim of this intervention study is to compare the effect of topical Rebamipide (regular and nanoparticulated) to topical Clobetasol propionate in management of Methotrexate induced oral mucositis in patients with rheumatoid arthritis.
Detailed description
A random sample of patients diagnosed with rheumatoid arthritis attending at the Rheumatology clinic in faculty of Medicine, Cairo University Hospital, will be enrolled by the investigator in the study in a consecutive order after being examined for methotrexate induced oral ulceration by means of history and clinical examination. Since oral mucositis associated with Methotrexate include production of free radicals, increase of inflammatory cytokines, and alteration of intracellular signal transduction, this suggests that Rebamipide should be useful for its treatment and prevention. Thus, this RCT will be the first to evaluate the treatment of Methotrexate-induced oral mucositis using Rebamipide and Rebamipide nanoparticles in patients with rheumatoid arthritis.
Interventions
DRUGRebamipide
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.
DRUGNanoparticulated Rebamipide
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.
A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient who agreed to sign the informed consent. * Age: 20-70 years old. * Gender: males and females * RA patients treated with MTX and suffering from MTX-induced oral ulceration.
Exclusion criteria
* Patients refused to sign the informed consent. * Pregnant or lactating females in their child bearing age group. * patients with known or suspected history of hypersensitivity to any of the ingredients of the preparation of the drugs used. * Systemic disease: such as uncontrolled diabetes mellitus, auto-immune diseases known to cause oral ulceration, renal or liver dysfunction or any other condition considered risky by the clinician. * Patients treated with any medication for the condition at the time of setting. * Salivary gland diseases. * Malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the Clinical improvement of oral ulcers | assessment will be at baseline, 2 weeks and 4 weeks | Will be assessed using World Health Organization (WHO) grading of mucositis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective degree of pain | Pain assessment will be daily for the first week then at 2 weeks and 4 weeks. | All patients were introduced to the Numerical Rating Scale (NRS) and learnt how to express their pain through it, patients were instructed to fill the scale paper at the first visit \[baseline\], this procedure was repeated for each follow-up visit. |
| size of oral ulcer | assessment at 0, 2 weeks and 4 weeks | The ulcer size was determined by measuring the distance between two opposite edges of the ulcer border, using a periodontal probe in millimeters. |
| healing time of the ulcer | assessment at 0, 2 weeks and 4 weeks | The total healing time of oral ulcers Will be recorded in days for all the patients. |
Countries
Egypt
Outcome results
None listed