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NCT05872464 | NOT YET RECRUITING | Xerostomia

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

Chulalongkorn University

Information provided by (Responsible Party):

Pornanong Aramwit, Pharm.D., Ph.D

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

Xerostomia

Intervention/treatment

Artificial saliva containing cumin and ginger extract

Placebo

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 52 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Actual Study Start Date : 2024-07-01
Estimated Primary Completion Date : 2025-05-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

Location Details

NCT05872464

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