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

NCT06114797 | Completed

• 1 other identifier: FDASU-Rec IR 042308
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia Due to Hyposecretion of Salivary Gland

Keywords

chamomile; Nitric oxide; hemodialysis; xerostomia; salivary flow rate

Outcome Measures

Primary Outcomes (1)

• The Summated Xerostomia Inventory (SXI)

  subjective severity of xerostomia using SXI score where the patient evaluates the frequency of complaints regarding five statements. Each statement has three possible replies: never, occasionally, or often, with scoring 1, 2, and 3, respectively. The SXI has a score range from (5 to 15), where a maximum score indicates severe problems related to dry mouth

  one month

Secondary Outcomes (4)

• Increase in unstimulated Salivary Flow Rate (ml/min)

  one month

• Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method

  one month

• The Oral Health Impact Profile (OHIP-14) questionnaire

  one month

• Serum creatinine and blood urea levels

  one month

Study Arms (2)

Chamomile mouthwash interventional arm in elderly patients having end-stage renal disease.

ACTIVE COMPARATOR

* Chamomile was topically applied to the oral mucosa as oral rinse. * Based on this protocol, patients were 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: Chamomile

Saline mouthwash control group in elderly patients having end-stage renal disease.

PLACEBO COMPARATOR

Patients in the control arm followed the same protocol with normal saline rinses. As stated before, 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 were benefited from the saline oral rinse.

Other: Saline mouthwash

Interventions

Chamomile OTHER

* 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.

Chamomile mouthwash interventional arm in elderly patients having end-stage renal disease.

Saline mouthwash OTHER

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

Saline mouthwash control group in elderly patients having end-stage renal disease.

Eligibility Criteria

• Age: 66 Years+
• Gender Eligibility Details: Both genders with end-stage renal disease
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 3753450, Egypt

Location

Related 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.

  PMID: 31809967 BACKGROUND

• 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.

  PMID: 25386217 BACKGROUND

• 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.

  PMID: 25175324 BACKGROUND

• 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.

  PMID: 11286806 BACKGROUND

• 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.

  PMID: 24690746 BACKGROUND

• 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.

  PMID: 15665029 BACKGROUND

MeSH Terms

Conditions

Xerostomia

Interventions

Chamomile extract

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants in both groups will not recognize the type of applied treatment whether it is saline mouthwash or chamomile mouthwash. Outcome assessor will not know whether the patients they are assessing are from the control or the intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Assistant

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: July 1, 2023
• Primary Completion: August 20, 2023
• Study Completion: September 1, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)