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

NCT ID: NCT06476223

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Artificial saliva containing cumin and ginger extract

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

Group Type: EXPERIMENTAL

Artificial saliva containing cumin and ginger extract

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Artificial saliva containing cumin and ginger extract

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0763/66

Identifier Type: -

Identifier Source: org_study_id