Xerostomia
Conditions
Brief summary
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.
Interventions
The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
DRUGPlacebo
The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Xerostomia symptoms using Xerostomia Inventory Score | 14 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary flow rate | 14 days | Weigh the saliva amount from the patients in 5 mins and then calculate in g/min |
| Amount of saliva score | 14 days | Patients give the score of saliva amount (0 to 10, 0 means no saliva and 10 means high amount of saliva) |
| Quality of life score using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 | 14 days | 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) |
| World Health Organization Oral Mucositis | 14 days | World Health Organization Oral Mucositis is graded 0 to 4 (0 means no mucositis to 4 means severe mucositis). |
| Acid and base of saliva | 14 days | Measure acid and base of saliva using acid and base standard paper |
Outcome results
None listed