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

ConditionXerostomia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with sialolith or Sjogren's syndrome

Uncontrolled other diseases

Using artificial saliva for more than 2 weeks

Taking pilocarpine and cevimeline

Trial design

Design model

Crossover

Treatments tested in this trial

  • Artificial saliva containing cumin and ginger extract

    Drug

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

  • Placebo

    Drug

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

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Artificial saliva containing cumin and ginger extractExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Salivary flow rate

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

Time frame
14 days
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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