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Assessing the effect of nanomisel curcumin on prevention and treatment of nanomisel curcumi

Phase 2
Recruiting
Conditions
Oral Candidiasis.
Candidal stomatitis/Oral thrush
B 37.0
Registration Number
IRCT20180416039318N3
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

the minimum age of 18 years, presence of head and neck cancer, radiation dose of 50-70 Gy, at least 50% of patient’s oral cavity in the field of radiation and patient satisfaction.

Exclusion Criteria

previous history of radiation therapy, patient dissatisfaction, history of allergy to turmeric, , in case of any oral lesions or complication resulting from radiation therapy other than candidiasis and mucositis, use of systemic or topical antifungal drugs for any reason, pregnancy or breastfeeding periods in women under treatment, presence of local and systemic conditions predisposing for candidiasis, such as the application of inhaled and topical steroids, presence of hyperkeratosis, use of immunosuppressive drugs, history of systemic antibiotic usage over the previous 2 weeks, the presence of CFU above 400/ml in the first culture or clinical evidence based on the presence of oral candidiasis.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Ccurrence of oral candidiasis. Timepoint: The first day of radiotherapy before radiation, every week until the end of the study. Method of measurement: Clinical examinations of oral lesion.;Candidate colony count in ml (colony forming unit = CFU). Timepoint: before the study, in the third week and the final week of radiotherapy. Method of measurement: Cultivation of oral lesions.
Secondary Outcome Measures
NameTimeMethod
Type of oral Candidiasis. Timepoint: before the study, in the third week and the final week of radiotherapy. Method of measurement: germ tube test and cultivation of oral lesions.
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