Explore (New York, N.Y.) · 2026
Advantages of artificial saliva containing Cuminum cyminum and Zingiber officinale on hemodialysis patients with xerostomia: Randomized clinical trials.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Napavichayanun Supamas, Srisawat Nattachai, Chaijamorn Weerachai, Aramwit Pornanong
Аннотация
INTRODUCTION: Xerostomia is a frequent complication among hemodialysis (HD) patients. Existing artificial saliva formulations offer limited relief, with short-lasting effects, high cost, and absence of salivary stimulation, posing accessibility challenges for patients, particularly in resource-limited settings. This study evaluated the safety of herbal artificial saliva (HAS) containing cumin and ginger in healthy volunteers and its efficacy and safety in HD patients with xerostomia.
MATERIALS AND METHODS: Phase I: Healthy volunteers were randomly assigned to the HAS group or the commercial artificial saliva (CAS) group. Safety assessments included xerostomia inventory scores, saliva salivary pH, and adverse reactions.
PHASE II: HD patients with xerostomia randomly divided into 2 groups. Group A used HAS 3 times daily for 2 weeks, paused for 2 weeks, and then used a placebo for 2 weeks. Group B followed the reverse procedure. Efficacy was assessed through saliva flow rates, dry mouth symptoms, quality of life evaluations, and adverse event monitoring.
RESULTS: HAS was safe for use in healthy volunteers and HD patients. Among HD patients, using HAS for at least 7 days significantly improved saliva flow rates compared to the placebo group (0.06 ± 0.08 g/min vs. 0.02 ± 0.06 g/min, p = 0.04). Furthermore, after 14 days of use, the dry mouth scores were significantly lower in the HAS group compared to the placebo group (p = 0.024).
CONCLUSION: These findings suggest that HAS shows promise as a potential alternative treatment for managing xerostomia in HD patients.
MATERIALS AND METHODS: Phase I: Healthy volunteers were randomly assigned to the HAS group or the commercial artificial saliva (CAS) group. Safety assessments included xerostomia inventory scores, saliva salivary pH, and adverse reactions.
PHASE II: HD patients with xerostomia randomly divided into 2 groups. Group A used HAS 3 times daily for 2 weeks, paused for 2 weeks, and then used a placebo for 2 weeks. Group B followed the reverse procedure. Efficacy was assessed through saliva flow rates, dry mouth symptoms, quality of life evaluations, and adverse event monitoring.
RESULTS: HAS was safe for use in healthy volunteers and HD patients. Among HD patients, using HAS for at least 7 days significantly improved saliva flow rates compared to the placebo group (0.06 ± 0.08 g/min vs. 0.02 ± 0.06 g/min, p = 0.04). Furthermore, after 14 days of use, the dry mouth scores were significantly lower in the HAS group compared to the placebo group (p = 0.024).
CONCLUSION: These findings suggest that HAS shows promise as a potential alternative treatment for managing xerostomia in HD patients.