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Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly

NCT06114797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-08-27

No results posted yet for this study

Summary

Background and Objectives: Chronic hemodialysis causes changes in blood chemistry as well as dry mouth, due to removal of excess fluids. Dry mouth is due to hyposalivation or change in saliva composition. Many herbal medicines have been used as treatment options. Since the chamomile was suggested as a potent oral moisturizer by previous studies that have been done in this field. Therefore, the investigators decided to assess the effect of chamomile oral rinse on the SXI score, salivary nitric oxide level, salivary flow rate, OHIP-14, serum creatinine and blood urea levels in elderly patients on chronic hemodialysis.

Material and Methods: It is an interventional randomized controlled clinical trial with a biochemical assessment. A chamomile, and placebo mouthwashes were provided to eighty-eight elderly participants with end-stage renal disease suffering from xerostomia. Patients were divided into 2 equal groups who used either the chamomile or placebo mouthwash for one month. The SXI score and salivary flow rate were evaluated for both groups at different intervals (baseline, 1 week, and 1 month). While salivary NO levels, OHIP-14, serum creatinine and blood urea levels evaluated at baseline and after one month only.

Conditions

  • Xerostomia Due to Hyposecretion of Salivary Gland

Interventions

OTHER

Chamomile

* Chamomile was topically applied to the oral mucosa as oral rinse. * Based on this protocol, patients had oral rinses 3 times per day. * Patients were instructed to perform chamomile rinses in the oral mucosa. * Patients were instructed not to swallow the chamomile oral rinse.

OTHER

Saline mouthwash

Saline mouthwash was used by elderly patients in the control arm.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2023-08-20
Completion
2023-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114797 on ClinicalTrials.gov