Clinical trial NCT06114797: Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly
Official title: Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly: A Randomized Clinical Trial With a Biochemical Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia Due to Hyposecretion of Salivary Gland
Keywords: chamomile
Nitric oxide
hemodialysis
xerostomia
salivary flow rate
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 88
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment protocol (for the intervention group):

* Chamomile will topically be applied to the oral mucosa as oral rinse based on the Morales-Bozo I et al., (2017) administration protocol.
* Based on this protocol, patients will have oral rinses 3 times per day.
* Patients will be instructed to perform chamomile rinses in the oral mucosa.
* Patients will be instructed not to swallow the chamomile oral rinse.

The control group (placebo):

Patients in the control arm followed the same protocol with normal saline rinses. As stated by Kim JO and Kim NC, 2014, that use of 4% hypertonic saline solution mouthwash by elderly provided better oral health by decreasing xerostomia, oral tongue plaque, halitosis, and the number of oral bacteria.

So the patients in the control group will be benefited from the saline oral rinse.
Primary purpose: TREATMENT

Brief 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.

Detailed description: A double-blind (interventional) cross-sectional clinical trial was performed on 88 participants in the hemodialysis center at Benha university. The inclusion criteria were both genders above 30 years of age with ESRD and complaints of dry mouth sensation. The exclusion criteria were significant salivary gland damage (for example, due to anticancer medication), radiotherapy or chemotherapy history, and allergies).

Bottles containing chamomile mouthwash or the placebo (A or B) were tagged by a reliable person outside the research group and placed inside an opaque envelope along with the questionnaires. Each patient received two envelopes containing a bottle (A \& B) and a questionnaire. The results were analyzed exclusively by a statistics consultant at the end of the research. The patients were asked to express their sensation of dry mouth using subjective dry mouth score.

The Summated Xerostomia Inventory (SXI) (Thomson et al., 2011; Frigaard et al., 2023):

ESRD patients who met the eligibility criteria were asked about their subjective severity of xerostomia using SXI score where the patient evaluates the frequency of complaints regarding five statements all recorded at 3 different intervals (at baseline- after 2 weeks- after 1 month).

Salivary flow rate: Eating and talking were prohibited during the time of collection. Unstimulated whole saliva was collected for 5 min by spitting method. The collection was timed, so that flow rate (mL/min) could be measured.

The Oral Health Impact Profile (OHIP-14) utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often) that was evaluated after one month in both groups. A lower score in any of the five categories indicates higher satisfaction (Al-Zubeidi et al., 2012).

Serum creatinine and blood urea levels were assessed at baseline and after one month in both groups.

Nitric oxide levels were determined by Nitric Oxide Assay Kit (Colorimetric) using Griess reaction: The Bio Diagnostic Nitrite Assay Kit provides an accurate and convenient method for measurement of endogenous nitrite concentration as an indicator of nitric oxide production in biological fluids. It depends on the addition of Griess Reagents which convert nitrite into a deep purple azo compound, photometric measurement of the absorbance due to this azo chromophore accurately determines NO2 - concentration.

Eligibility criteria: Inclusion Criteria:

* Both genders, aged above 65 years.

  * All patients must be clinically diagnosed of ESRD undergoing hemodialysis.
  * Patients on hemodialysis ≥ 3 months (Bots et al., 2005).
  * All patients must have complaint of xerostomia.
  * Patients must be able to make reliable decision or communications.

Exclusion Criteria:

* - Smoking, Alcohol.
* Patient with history of any serious illness as malignancy, who undergo kidney transplant.
* Patients with any autoimmune disease.
* Vulnerable groups such as prisoners, mentally and physically handicapped individuals.

Primary outcomes:
measure: The Summated Xerostomia Inventory (SXI)
timeFrame: one month
Secondary outcomes:
measure: Increase in unstimulated Salivary Flow Rate (ml/min)
timeFrame: one month
measure: Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method
timeFrame: one month
measure: The Oral Health Impact Profile (OHIP-14) questionnaire
timeFrame: one month
measure: Serum creatinine and blood urea levels
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
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