Testing artificial saliva with cumin and ginger extract for safety
Efficacy (Preliminary) and Safety of Artificial Salivary Containing Cumin and Ginger Extract in Healthy Volunteer
NA · Chulalongkorn University · NCT04997889
This study is testing if a new artificial saliva with cumin and ginger extract is safe for healthy people compared to a regular product.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chulalongkorn University (other) |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT04997889 on ClinicalTrials.gov |
What this trial studies
This preliminary clinical study evaluates the safety of artificial saliva containing cumin and ginger extract in healthy volunteers. Initially, 21 participants will be divided into three groups to assess different concentrations of the extracts. Following this, a larger group of 112 volunteers will compare the artificial saliva with a commercial product. Evaluations will include salivary volume, acidity, and potential adverse effects using standardized questionnaires and tests over a specified duration.
Who should consider this trial
Good fit: Ideal candidates are healthy adults over 18 years old without a history of dry mouth or salivary gland issues.
Not a fit: Patients with uncontrolled diseases, dry mouth, or salivary gland disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective artificial saliva product for individuals experiencing dry mouth.
How similar studies have performed: While this approach is novel, similar studies evaluating herbal extracts for health benefits have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok
- Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity — Bangkok, Thailand (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Health, Subjective