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

NCT06476223 | Not Yet Recruiting

• 1 other identifier: 0763/66
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Xerostomia

Outcome Measures

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)

  14 days

Secondary Outcomes (5)

• Salivary flow rate

  14 days

• Amount of saliva score

  14 days

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

  14 days

• World Health Organization Oral Mucositis

  14 days

• Acid and base of saliva

  14 days

Study Arms (2)

Artificial saliva containing cumin and ginger extract

EXPERIMENTAL

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

Drug: Artificial saliva containing cumin and ginger extract

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Artificial saliva containing cumin and ginger extract DRUG

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

Artificial saliva containing cumin and ginger extract

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Xerostomia

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 31, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06