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J Thai Trad Alt Med Vol. 21 No. 3 Sep-Dec 2023 521

2. Safety analysis burning sensation. The oral dryness/thirsty
Patients were asked to list any specific and burning sensation were also reported
side effects and their response are recorded mainly in patients-treated with CHI-CUR

in Table 3. No serious side effects were no- mouthwash. A few patients-treated with CHI-
ticed in either patient group and none of the CUR mouthwash could feel mild to moderate
patients had to leave the study because of nausea. Yellow staining on the tongue was
oral or systemic adverse events. The major found after rinsing the CHI-CUR mouthwash,

adverse effects reported in patients-treated however, the staining disappeared after drink-
with TA mouthwash were oral dryness/thirsty, ing or eating.
hypersalivation, decreased tasting and a

Table 3 Patient safety reported during the course of study
Patient’s safety TA (n = 10) CHI-CUR (n = 9)

Oral dryness/thirsty 5 3
Difficulty in speaking 1 2
Difficulty in drinking/eating 2 0
Nausea/vomiting
Mild to moderate 1 3
Severe 0 0
Decreased food consumption 2 1
Difficulty in sleeping 1 1
Cramping/diarrhea 1 1
Staining on the tongue 0 0
Decreased tasting 3 1
Bitter/dull/astringent taste 3 3
Hypersalivation 3 1
Burning sensation 4 3

TA = 0.1% triamcinolone acetonide mouthwash
CHI-CUR = 0.1% alcohol-free chitosan-curcuminoids mouthwash

Discussion to which mouthwash it was. The preparation

The design of the present study needed of CHI-CUR formulation was naturally clear but
to be a single-blinded randomized controlled yellow color solution whereas the TA formula-

trial. Both CHI-CUR and TA mouthwash were tion was a clear and colorless solution so that
delivered in an amber glass bottle to the phar- the participants especially in whom who had
macist and the investigator who were blind as ever use TA mouthwash may be able to iden-