Clinical trial NCT04997889: Efficacy (Preliminary) and Safety of Artificial Salivary Containing Cumin and Ginger Extract in Healthy Volunteer
Official title: Efficacy (Preliminary) and Safety of Artificial Salivary Containing Cumin and Ginger Extract in Healthy Volunteer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health, Subjective
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Salivary acid and base value
timeFrame: 6 days
Secondary outcomes:
measure: Mucositis
timeFrame: 6 days
measure: Adverse event
timeFrame: 6 days
measure: Dry mouth status
timeFrame: 6 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
References: