Artificial Saliva Containing Cumin and Ginger Extract in Hemodialysis Patients With Xerostomia

Chulalongkorn University

Status: Not yet enrolling

Conditions: Xerostomia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06476223

0763/66

Details and patient eligibility

About

Hemodialysis patients with xerostomia are divided into 2 groups which are group A (start with artificial saliva containing cumin and ginger extract for 2 weeks, free periods 2 weeks, then placebo for 2 weeks) and group B (start with placebo for 2 weeks, free periods 2 weeks, then artificial saliva containing cumin and ginger extract for 2 weeks). Amount of saliva (g/min), xerostomia's questionnaire, Increase of saliva score, World Health Organization Oral Mucositis Grading Scale, acid and base of saliva, quality of life's questionnaire will measure before, after using the sample for 7 and 14 days.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age more than 18 years
• Hemodialysis patients with xerostomia (saliva flow rate less than 0.2 g/min)
• Hemodialysed history more than 3 months
• Be willing to participate in the study

Exclusion criteria

• Patients with sialolith or Sjogren's syndrome
• Uncontrolled other diseases
• Using artificial saliva for more than 2 weeks
• Taking pilocarpine and cevimeline
• Allergic to ginger, cumin, xylitol, and glycerin
• Have mucositis
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Artificial saliva containing cumin and ginger extract

Experimental group

Description:

The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.

Treatment:

Drug: Artificial saliva containing cumin and ginger extract

Placebo

Placebo Comparator group

Description:

The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.

Treatment:

Drug: Placebo