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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

Not Applicable

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 : July 1, 2023
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : September 26, 2023
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

Placebo Comparator: Placebo

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

Other: Placebo

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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