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

Not Applicable

Recruiting

• Conditions: Health, Subjective
• Interventions: Combination Product: Artificial salivary containing cumin and ginger extract; Other: Commercial artificial salivary

• Registration Number: NCT04997889
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Study Start: 2024-02-15
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
artificial salivary containing cumin and ginger extract	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.
Commercial artificial salivary	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.

Primary Outcome Measures

Name	Time	Method
Salivary acid and base value	6 days	Salivary acid and base value (scale 0 (acid) to 14 (base)) using strip test

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity; 🇹🇭 Bangkok, Thailand