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

Xerostomia Due to Hyposecretion of Salivary Gland Clinical Trial

Official title:

Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly: A Randomized Clinical Trial With a Biochemical Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06114797
• Other study ID #: FDASU-Rec IR 042308
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 salivary nitric oxide level, salivary flow rate and salivary pH 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 following clinical parameters (salivary flow rate, salivary ph, and salivary nitric oxide (NO) levels) were evaluated for both groups at different intervals (baseline, 1 week, and 1 month).

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.

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.

Salivary pH: Following saliva collection, pH was measured immediately using the narrow range pH strip system (Merck). One drop of the collected saliva was placed on the test strip and its color change reflected the pH of saliva.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 1, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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.

• Objective dry mouth score from (2-5).

• Subjective dry mouth score from (1-4).

• 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.

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Xerostomia
• Xerostomia Due to Hyposecretion of Salivary Gland

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Afsaneh Abadi P, Koopaie M, Montazeri R. Comparison of salivary nitric oxide and oral health in diabetic patients with and without xerostomia. Diabetes Metab Syndr. 2020 Jan-Feb;14(1):11-15. doi: 10.1016/j.dsx.2019.11.014. Epub 2019 Nov 25. — View Citation

Alam F, Islam MA, Gan SH, Khalil MI. Honey: a potential therapeutic agent for managing diabetic wounds. Evid Based Complement Alternat Med. 2014;2014:169130. doi: 10.1155/2014/169130. Epub 2014 Oct 15. — View Citation

Anil S, Vellappally S, Hashem M, Preethanath RS, Patil S, Samaranayake LP. Xerostomia in geriatric patients: a burgeoning global concern. J Investig Clin Dent. 2016 Feb;7(1):5-12. doi: 10.1111/jicd.12120. Epub 2014 Sep 1. — View Citation

Bardow A, Nyvad B, Nauntofte B. Relationships between medication intake, complaints of dry mouth, salivary flow rate and composition, and the rate of tooth demineralization in situ. Arch Oral Biol. 2001 May;46(5):413-23. doi: 10.1016/s0003-9969(01)00003-6. — View Citation

Belcher J. Dressings and healing with honey. Br J Nurs. 2014 Mar 27-Apr 9;23(6):S22. doi: 10.12968/bjon.2014.23.Sup6.S22. — View Citation

Bots CP, Brand HS, Veerman EC, Korevaar JC, Valentijn-Benz M, Bezemer PD, Valentijn RM, Vos PF, Bijlsma JA, ter Wee PM, Van Amerongen BM, Nieuw Amerongen AV. Chewing gum and a saliva substitute alleviate thirst and xerostomia in patients on haemodialysis. Nephrol Dial Transplant. 2005 Mar;20(3):578-84. doi: 10.1093/ndt/gfh675. Epub 2005 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subjective dry mouth score	Changes in subjective dry mouth score [ Time Frame: baseline, 2 weeks and 4 weeks after intervention] The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of chamomile mouth rinse (for at least 5 days per week) the maximum score is the worst and the minimum score is the best.	one month
Secondary	Increase in unstimulated Salivary Flow Rate (ml/min)	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 normal unstimulated salivary flow rate is approximately 0.3-0.4 mL/min. A diagnosis of hyposalivation is made when the unstimulated salivary flow rate is =0.1 mL/min.; Time Frame: baseline, 2 weeks and 4 weeks after intervention ] The outcome measure will be measured before and 2 and 4 weeks after continuous usage of chamomile mouth rinse (for at least 5 days per week)	one month
Secondary	Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method	Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method [ Time Frame: baseline and 4 weeks after intervention] The outcome measure will be measured before and 4 weeks after continuous usage of chamomile mouth rinse (for at least 5 days per week).	one month
Secondary	Changes in objective dry mouth score	Changes in objective dry mouth score [ Time Frame: baseline, 2 weeks and 4 weeks after intervention] The outcome measure will be measured before and 2 and 4 weeks after continuous usage of chamomile mouth rinse (for at least 5 days per week) The maximum score is the worst and the minimum score is the best.	one month
Secondary	Changes in salivary Potential of Hydrogen ion (pH)	Changes in salivary Potential of Hydrogen ion (pH) [ Time Frame: baseline, 2 weeks and 4 weeks after intervention ] The outcome measure will be measured before and 2 and 4 weeks after continuous usage of chamomile mouth rinse (for at least 5 days per week)	one month