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Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

Sponsor
Chulalongkorn University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05872464
Collaborator
(none)
52
Enrollment
2
Arms
2.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.

Condition or Disease Intervention/Treatment Phase
  • Other: Artificial saliva containing cumin and ginger extract
  • Other: Placebo
 N/A

Detailed Description

There are 52 patients in this study. They are divided into 2 groups which are artificial saliva containing cumin and ginger extract group (test group) 26 patients and placebo group 26 patients. The patients spray the sample into the mouth 3 times/day for 14 day. Amount of saliva, pH of saliva, xerostomia questionnaires, WHO Oral Mucositis Grading Scale, quality of life, adverse events, and satisfaction were assessed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 26, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Artificial saliva containing cumin and ginger extract

Artificial saliva containing cumin and ginger extract in spray bottle

Other: Artificial saliva containing cumin and ginger extract
Artificial saliva containing cumin and ginger extract in spray bottle
Placebo Comparator: Placebo

Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Other: Placebo
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Outcome Measures

Primary Outcome Measures

  1. Amount of saliva [14 days]

    Spit saliva to the bottle for 5 min

Secondary Outcome Measures

  1. Acid and base characteristic of saliva [14 days]

    Spit saliva to the bottle, then take 1 piece of pH strip and dip it into the saliva for 30 seconds. Compare the color of the dipped pH strip to the color chart on pH strip box. The result shows value at pH 1-14.

  2. Xerostomia questionnaires [14 days]

    Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).

  3. Oral Mucositis Grading Scale [14 days]

    Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).

  4. Adverse reaction: Skin reaction [14 days]

    Found or not found

  5. Adverse reaction: Respiratory reaction [14 days]

    Found or not found

  6. Adverse reaction: Gastrointestinal trat reaction [14 days]

    Found or not found

  7. Quality of life of the patient [14 days]

    Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)).

  8. Satisfaction of the patient [14 days]

    Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age more than 18 years

  • Head and neck cancer with xerostomia

  • 6 months post radiation

  • Willing to participate in this study

Exclusion Criteria:

  • Sialolith or Sjogren's syndrome

  • Uncontrolled cancer

  • Using artificial saliva more than 2 weeks

  • Taking Pilocarpine or cevimeline more than 2 weeks

  • Allergic to cumin, ginger, xylitol, and glycerin

  • History of other oral mucosal diseases

  • Pregnancy and lactation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chulalongkorn University

Investigators

  • Principal Investigator: Pornanong Aramwit, Professor, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT05872464
Other Study ID Numbers:
  • Med CU IRB 0489/65
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia

Study Results

No Results Posted as of May 24, 2023