NCT04997889

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health, Subjective

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Artificial 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.
OTHER	Commercial 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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-06-30
• Completion: 2024-07-31
• First posted: 2021-08-10
• Last updated: 2024-02-07

Locations

1 site across 1 country: Thailand