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

0763/66

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 questionnair, Increase of saliva score, WHO Oral Mucositis Grading Scale, pH of saliva, quality of life's questionnair will measure before, after using the sample for 7 and 14 days.

2024-07-01

2024-12-30

2025-01-31

Not yet recruiting

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}

2024-06-26