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Evaluation of the efficacy of oral curcumin on complex aphthous

Phase 2
Recruiting
Conditions
Oral complex aphthous.
Recurrent oral aphthae
K12.0
Registration Number
IRCT20100101002950N7
Lead Sponsor
Rasht University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
15
Inclusion Criteria

Patients between the ages of 20 and 60 years
Complex aphthous ulcers, which include: a number of painful aphthous lesions on the oral mucosa that appear intermittently and heal slowly;
Created in less than 72 hours

Exclusion Criteria

Patients taking topical medication to treat the aphthous in the last two weeks or taking systemic medication in the last one month
Patients with systemic diseases such as intestinal and gastric diseases (Crohn's and ulcerative colitis), Behcet's disease, Reiter's syndrome and gallstones
Patients with anxiety disorders
Patients with bracets
Pregnant and lactating women
Patients with a history of alcohol and drug use
Patients treated with immunosuppressants, chemotherapy, and immunomodulatory drugs over the past year
History of allergies to plant compounds, including turmeric
High liver enzymes
Use of anticoagulants or antiplatelets (curcumin has an inhibitory effect on platelet aggregation) such as Warfarin, Aspirin, Clopidogrel, Epixaban, Rivaroxaban, Heparin and Enoxaparin
History of gastric ulcer and duodenal ulcer
Patients with inadequate literacy who do not understand the consent form

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Functional complications. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Use of visual analoge scale (VAS) from 0-10. 0: The least discomfort and interference of the lesions with the patient speaking, chewing and brushing. 10: The highest amount of interference.;The recurrence of ulcers. Timepoint: 2, 4 and 8weeks after consumption of the medicine. Method of measurement: With physical examination of patients and based on the time after taking the drug that the disease will occurs again.;The number of aphthous lesion. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Count the number of lesions through examination.;Patient satisfaction with treatment. Timepoint: 2, 4 and 8weeks after consumption of the medicine. Method of measurement: Use of visual analoge scale. 0-7: Dissatisfaction 8-10: Satisfaction.
Secondary Outcome Measures
NameTimeMethod
The size of aphthous lesion. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Using a sterile vernier caliper.;The severity of pain. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Use of visual analoge scale (VAS) from 0-10. 0:no pain - 10: severe pain.
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