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

NCT04997889 | Recruiting

• 1 other identifier: EC2105120
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (1)

• Salivary acid and base value

  Salivary acid and base value (scale 0 (acid) to 14 (base)) using strip test

  6 days

Secondary Outcomes (3)

• Mucositis

  6 days

• Adverse event

  6 days

• Dry mouth status

  6 days

Study Arms (2)

artificial salivary containing cumin and ginger extract

EXPERIMENTAL

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

Commercial artificial salivary

ACTIVE COMPARATOR

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

Interventions

Artificial salivary containing cumin and ginger extract COMBINATION_PRODUCT

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.

artificial salivary containing cumin and ginger extract

Commercial artificial salivary OTHER

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.

Commercial artificial salivary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled disease
• Dry mouth
• Salivary gland disease, inflammation, or sialolith
• Pregnancy or lactation
• During participated in other study

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, 10310, Thailand

RECRUITING

MeSH Terms

Interventions

ginger extract

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 10, 2021
• Study Start: February 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

TH (1)