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Efficacy (Preliminary) and Safety of Artificial Salivary Containing Cumin and Ginger Extract in Healthy Volunteer

Health, Subjective Clinical Trial

Official title:
Efficacy (Preliminary) and Safety of Artificial Salivary Containing Cumin and Ginger Extract in Healthy Volunteer

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04997889
Study type Interventional
Source Chulalongkorn University
Contact
Status Recruiting
Phase N/A
Start date February 15, 2024
Completion date July 31, 2024
View Details
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