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

Chulalongkorn University26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Xerostomia

Interventions

Artificial saliva containing cumin and ginger extract

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Xerostomia symptoms using Xerostomia Inventory Score

Patients give the score of Xerostomia Inventory questionnaire. The Xerostomia Inventory Score is graded 11 to 55 (Low score means low frequency xerostomia and high score means high frequency of xerostomia)

Time frame: 14 days

Secondary Outcomes

Salivary flow rate

Weigh the saliva amount from the patients in 5 mins and then calculate in g/min

Time frame: 14 days

Amount of saliva score

Patients give the score of saliva amount (0 to 10, 0 means no saliva and 10 means high amount of saliva)

Time frame: 14 days

Quality of life score using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35

Patients give the score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35. The score is graded 35 to 130 (Low score means high quality of life and high score means low quality of life)

Time frame: 14 days

World Health Organization Oral Mucositis

World Health Organization Oral Mucositis is graded 0 to 4 (0 means no mucositis to 4 means severe mucositis).

Time frame: 14 days

Acid and base of saliva

Measure acid and base of saliva using acid and base standard paper

Time frame: 14 days