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

Not Applicable

Not yet recruiting

• Conditions: Xerostomia
• Interventions: Drug: Placebo; Drug: Artificial saliva containing cumin and ginger extract

• Registration Number: NCT06476223
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-26
• Last Update Submitted: 2024-06-28
• Study Start: 2024-07-01
• Last Update Posted: 2024-07-01
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
Artificial saliva containing cumin and ginger extract	Artificial saliva containing cumin and ginger extract	The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Acid and base of saliva	14 days	Measure acid and base of saliva using acid and base standard paper
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).