Xerostomia Due to Hyposecretion of Salivary GlandNCT06114797
Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly
A study testing Chamomile and Saline mouthwash in people with Xerostomia Due to Hyposecretion of Salivary Gland, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Xerostomia Due to Hyposecretion of Salivary Gland
- What is being tested?
- Chamomile and Saline mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly: A Randomized Clinical Trial With a Biochemical Assessment
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.
Read the 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.
- Being tested
- Chamomile, Saline mouthwash
- Keywords
- chamomile, Nitric oxide, hemodialysis, xerostomia, salivary flow rate
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChamomileOther
- 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 mouthwashOther
Saline mouthwash was used by elderly patients in the control arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Saline mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Secondary outcomes (4)
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)
Measured: one month
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).
Measured: one month
The Oral Health Impact Profile (OHIP-14) questionnaire
(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
Measured: one month
Serum creatinine and blood urea levels
Kidney clinical parameters to evaluate the renal function, higher values are the worst, and lower values are the best.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jul 2023
- Primary completion20 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Xerostomia Due to Hyposecretion of Salivary GlandStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Aboubakr, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114797
- Sponsor's protocol ID
- FDASU-Rec IR 042308
- Status last verified
- Aug 2024
- First submitted
- 27 Oct 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will not share my raw data
Publications
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.
PubMed 31809967Alam 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.
PubMed 25386217Anil 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.
PubMed 25175324Bardow 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.
PubMed 11286806Belcher 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.
PubMed 24690746Bots 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.
PubMed 15665029
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly: A Randomized Clinical Trial With a Biochemical Assessment
- ClinicalTrials.gov ID
- NCT06114797
- Acronym / sponsor ID
- FDASU-Rec IR 042308
- Keywords
- chamomile, Nitric oxide, hemodialysis, xerostomia, salivary flow rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chamomile mouthwash interventional arm in elderly patients having end-stage renal disease. | Active comparator | Other: Chamomile* 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. |
| Saline mouthwash control group in elderly patients having end-stage renal disease. | Placebo comparator | Other: Saline mouthwashPatients 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. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Both genders, aged above 65 years.
Key exclusion criteria (4 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Chamomile mouthwash interventional arm in elderly patients having end-stage renal disease. |
| Saline mouthwashSaline mouthwash was used by elderly patients in the control arm. | Other | Saline mouthwash control group in elderly patients having end-stage renal disease. |
Primary outcome
The Summated Xerostomia Inventory (SXI)
Time frame: one month
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
4 secondary outcomes
Increase in unstimulated Salivary Flow Rate (ml/min)
Time frame: one month
Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method
Time frame: one month
The Oral Health Impact Profile (OHIP-14) questionnaire
Time frame: one month
Serum creatinine and blood urea levels
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 31809967Afsaneh 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.
- Background: PubMed 25386217Alam 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.
- Background: PubMed 25175324Anil 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.
- Background: PubMed 11286806Bardow 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.
- Background: PubMed 24690746Belcher 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.
- Background: PubMed 15665029Bots 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.
- Individual participant dataSharing planned: No. will not share my raw data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chamomile and Saline mouthwash in people with Xerostomia Due to Hyposecretion of Salivary Gland, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Summated Xerostomia Inventory (SXI) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06114797, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.