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

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.

Study Overview

• Status: Recruiting
• Conditions: Health, Subjective
• Intervention / Treatment: Combination product: Artificial salivary containing cumin and ginger extract; Other: 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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10310
    • Recruiting
    • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
    • Contact: Pornanong Aramwit, Ph.D; Phone Number: +66899217255; Email: aramwit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary acid and base value	Salivary acid and base value (scale 0 (acid) to 14 (base)) using strip test	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucositis	Mucositis using World Health Organization Oral Mucositis Grading Scale (scale 0 (none) to 4 (life-threatening)	6 days
Adverse event	Adverse event using questionnaire (Yes or No)	6 days
Dry mouth status	Dry mouth status using questionnaire (scale 0 (none) to 10 (severe symptom)	6 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EC2105120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No