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

Chulalongkorn University

Status: Not yet enrolling

Conditions: Xerostomia

Treatments: Other: Placebo; Other: Artificial saliva containing cumin and ginger extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05872464

R177h/66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Artificial saliva containing cumin and ginger extract

Experimental group

Description:

Artificial saliva containing cumin and ginger extract in spray bottle

Treatment:

Other: Artificial saliva containing cumin and ginger extract

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo