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

Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Hemodialysis

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 Overview

• Status: Not yet recruiting
• Conditions: Xerostomia
• Intervention / Treatment: Drug: Artificial saliva containing cumin and ginger extract; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artificial saliva containing cumin and ginger extract; The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.	Drug: Artificial saliva containing cumin and ginger extract; The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
Placebo Comparator: Placebo; The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.	Drug: Placebo; The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary flow rate	Weigh the saliva amount from the patients in 5 mins and then calculate in g/min	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)	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)	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).	14 days
Acid and base of saliva	Measure acid and base of saliva using acid and base standard paper	14 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: 0763/66

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No