Health, Subjective
Conditions
Brief summary
This study is a preliminary clinical study about safety of artificial salivary containing cumin and ginger extract in 21 healthy volunteers. After the preliminary clinical study, safety of artificial salivary containing cumin and ginger extract in 112 healthy volunteers. The volunteers will be divided into 2 groups which are artificial salivary containing cumin and ginger extract group and commercial artificial salivary.
Detailed description
This study is a preliminary clinical study about safety of artificial salivary containing cumin and ginger extract in 21 healthy volunteers. The volunteers will be divided into 3 groups which are artificial salivary containing 0.3% cumin and 0.05%ginger extract group, artificial salivary containing 0.3%cumin and 0.1%ginger extract group, and artificial salivary containing 0.3%cumin and 0.15%ginger extract group. The volunteers will be evaluated salivary volume by Schirmer test, salivary acid and base value by strip test, dry mouth by questionnaire, and adverse effects before and after using the artificial salivary for 30 min. After the preliminary clinical study, safety of artificial salivary containing cumin and ginger extract in 112 healthy volunteers. The volunteers will be divided into 2 groups which are artificial salivary containing cumin and ginger extract group and commercial artificial salivary. The volunteers will be evaluated salivary acid and base value by strip test and adverse effects by World Health Organization Oral Mucositis Grading Scale and questionnaire before and after using the artificial salivary (3 times/day) for 3 and 6 days. Then, the volunteers will stop using the artificial salivary for 7-10 days. After that, the volunteers will be used the artificial salivary for 3 days. All evaluation will be tested.
Interventions
COMBINATION_PRODUCTArtificial salivary containing cumin and ginger extract
The artificial salivary containing cumin and ginger extract will be used 2 g/time (3 times/day) into the mouth for 6 days. Then, the artificial salivary containing cumin and ginger extract will be stopped for 7-10 days. After that, the artificial salivary containing cumin and ginger extract will be used 2 g/time (3 times/day) into the mouth for 3 days.
OTHERCommercial artificial salivary
The commercial artificial salivary will be used 2 g/time (3 times/day) into the mouth for 6 days. Then, the commercial artificial salivary will be stopped for 7-10 days. After that, the commercial artificial salivary will be used 2 g/time (3 times/day) into the mouth for 3 days.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age more than 18 years * World Health Organization Oral Mucositis Grading Scale =0 * No using artificial salivary or activated salivary medicine more than 2 weeks * No cumin, ginger, xylitol, glycerin allergy * Have a willingness to participate in the study
Exclusion criteria
* Uncontrolled disease * Dry mouth * Salivary gland disease, inflammation, or sialolith * Pregnancy or lactation * During participated in other study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary acid and base value | 6 days | Salivary acid and base value (scale 0 (acid) to 14 (base)) using strip test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mucositis | 6 days | Mucositis using World Health Organization Oral Mucositis Grading Scale (scale 0 (none) to 4 (life-threatening) |
| Adverse event | 6 days | Adverse event using questionnaire (Yes or No) |
| Dry mouth status | 6 days | Dry mouth status using questionnaire (scale 0 (none) to 10 (severe symptom) |
Countries
Thailand
Outcome results
None listed