XerostomiaNCT05247008
Effectiveness of Thyme Honey in Management of Xerostomia in ESRD
A study testing Thyme honey in people with Xerostomia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The oral health of older people has warranted considerable research attention in the last two to three decades. One of the most oral conditions that have been related to the elderly patients was xerostomia. An elderly population that has a high rate of comorbid disease is likely to continue for the foreseeable future. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Thyme honey
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2021to 10 Oct 2021
- 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 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders, of minimum 61 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.
Who cannot join
- - Smoking, Alcohol. Healthy patients.
- Patient with history of any serious illness as malignancy, who undergo kidney transplant.
- Patients with any autoimmune disease.
- Patients with diabetes mellitus (Charalambous et al., 2017).
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Thyme Honey in Management of Xerostomia in Geriatric Patients With ESRD: Longitudinal Prospective Clinical Biochemical Study
The oral health of older people has warranted considerable research attention in the last two to three decades. One of the most oral conditions that have been related to the elderly patients was xerostomia.
An elderly population that has a high rate of comorbid disease is likely to continue for the foreseeable future. Among these pathologies, End stage renal disease (ESRD) stands out as a common serious age-related disease. ESRD is a chronic irreversible renal failure. It is known also as chronic kidney disease (CKD) Stage 6 or CKD 6. Xerostomia is relatively common in patients having ESRD with prevalence ranging from 28% to 67%.
Read more
Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients with ESRD which were based on the stimulation of the salivary gland flow.
A new alternative for the control of xerostomia is the use of thyme honey, which is a propolis gel product with strong antioxidant, antibacterial, antifungal and immunomodulation effect. It is believed that the presence of honey in the oral cavity has a sialagogue effect, stimulating the salivary glands to produce more saliva, due to the high sugar concentration in honey.
The purpose of the study is to determine whether the use of thyme honey as mouth rinse will help in the treatment of xerostomia in geriatric patients with end-stage renal disease (symptom management).
Read the detailed description
Most patients with end-stage renal disease (ESRD) on hemodialysis (HD) have to maintain a fluid-restricted diet in order to prevent fluid overload between dialysis sessions. . However, compliance to the fluid restriction is also influenced by other factors, such as hormonal derangements, social and psychological changes, thirst and xerostomia.
Xerostomia in ESRD is a multifactorial phenomenon and various mechanisms contribute to its development as direct uremic involvement of salivary glands, atrophy and fibrosis of the salivary glands, chemical inflammation, dehydration, mouth breathing. The other conditions that may cause dry mouth in uremic patients are retrograde parotitis, metabolic abnormalities, use of diuretics and due to inability of kidneys to reabsorb sodium and the resultant polyuria.
Xerostomia, the subjective feeling of oral dryness, is a symptom most frequently accompanied by either decreased salivary flow or an altered composition of saliva. Hyposalivation, on the other hand, is the objective measured reduction in salivary flow rate. Xerostomia is a relatively common complaint, particularly among older people, and can lead to major consequences with regard to the quality of their general and oral health and wellbeing.
Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.
Secondary causes of xerostomia include the side-effects of radiation therapy or chemotherapy, rheumatoid arthritis, scleroderma, mixed connective tissues diseases, systemic lupus erythematous, graft versus host disease, anorexia, alcohol and smoking and commonly prescribed drugs (>500 medications reportedly cause dry mouth). The most common medications causing hyposalivation are those with anticholinergic activity, sympathomimetics, and benzodiazepines. The risk of xerostomia increases with the synergistic effects of xerogenic medications, multiple medications, higher doses of medication, and the duration of the medication.
Saliva plays an important role in maintaining the physiological homeostasis of the oral cavity. In addition to humidifying the oral tissues, its lubricating properties aid in swallowing and talking, and also prevent damage due to mechanical agents. Saliva contains a variety of electrolytes, peptides, glycoproteins, enzymes, immunoglobulin A, amines, and leucocytes.
Owing to the multiple functions of saliva, hyposalivation leads to speech problems, taste disorders, chewing and swallowing difficulties, ill-fitting dentures and consequently poor qualities of life. Furthermore, hyposalivation results in decreased oral clearance, declined salivary pH and buffering capacity, and reduced immune defenses. These symptoms may increase risks of developing infectious oral diseases such as cervical caries, periodontitis and oral candidiasis.
Among saliva constituents, the nitric oxide (NO) is a biochemical marker that involved in both physiological and pathological processes of the salivary glands. High concentrations of nitrate and nitrite (stable metabolites of NO) in normal saliva may ensure potentially protective effects, such as antibacterial properties, increased mucosal blood flow, and oral mucus production.
Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients with ESRD which were based on the stimulation of the salivary gland flow. Salivary glands can be stimulated to produce saliva mechanically (for example, by chewing gum, using different formulated mouthwashes or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting enzyme inhibitors and angiotensin-receptor antagonists.
Overall, the available interventions do not appear to provide an effective, comprehensive and long-term management of xerostomia. This has strengthened the need for further investigation of other interventions for the management of xerostomia.
A new alternative for the control of xerostomia is the use of thyme honey, which is a propolis gel product with strong antioxidant, antibacterial, antifungal and immunomodulation effect. It is believed that the presence of honey in the oral cavity has a sialagogue effect, stimulating the salivary glands to produce more saliva, due to the high sugar concentration in honey.
Honey has been used historically for its medicinal properties. It has been used to heal burns, surgical wounds, and oral infections because of its antibacterial and analgesic agents and epithelialization boosting effect. Honey has no side effects like other pharmaceutical drugs due to its properties.
As Egypt is considered a low-income country, therefore, the general properties of ideal saliva substitutes to be used should be inexpensive, edible, hydrating, safe-to-swallow but retainable in the mouth.
Given the importance of the oral health status of older people with ESRD associated with xerostomia and thinking that the saliva substitutes or stimulants could potentially be used to decrease this complaint, thus, the urge to drink in hemodialysis patients. This may increase compliance to the fluid-restricted diet and could, subsequently, result in improvement in their quality of life. This study is designed to evaluate the efficiency of different and natural treatment as thyme honey in management of geriatric Egyptian patients with xerostomia and its association to the level of salivary nitric oxide.
- Conditions
- Xerostomia
- Being tested
- Thyme honey
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyme honeyOther
- Thyme honey will topically be applied to the oral mucosa as oral rinse based on the Biswal et al. (2003) administration protocol.
- Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Thyme honey interventional arm in geriatric patients having end-stage renal disease. | Other | Thyme honey used as mouth rinse in treatment of xerostomia in geriatric patients with end-stage renal disease. Receives: Other: Thyme honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 thyme honey mouth rinse (for at least 5 days per week)
Measured: one month
Secondary outcomes (4)
Increase in unstimulated Salivary Flow Rate (ml/min)
Increase in unstimulated Salivary Flow Rate (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 thyme honey 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 thyme honey mouth rinse (for at least 5 days per week).
Measured: one month
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 thyme honey mouth rinse (for at least 5 days per week)
Measured: one month
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 thyme honey mouth rinse (for at least 5 days per week)
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 posted18 Feb 2022
- Study start10 Sep 2021
- Primary completion1 Oct 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment protocol: * Thyme honey will topically be applied to the oral mucosa as oral rinse based on the Biswal et al. (2003) administration protocol. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247008
- Sponsor's protocol ID
- 972
- Status last verified
- Feb 2021
- First submitted
- 29 Oct 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24690746Biswal BM, Zakaria A, Ahmad NM. Topical application of honey in the management of radiation mucositis: a preliminary study. Support Care Cancer. 2003 Apr;11(4):242-8. doi: 10.1007/s00520-003-0443-y. Epub 2003 Feb 19.
PubMed 12673463Bossola M. Xerostomia in patients on chronic hemodialysis: An update. Semin Dial. 2019 Sep;32(5):467-474. doi: 10.1111/sdi.12821. Epub 2019 May 22.
PubMed 31117154Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Ter Wee PM, Amerongen AV. Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int. 2004 Oct;66(4):1662-8. doi: 10.1111/j.1523-1755.2004.00933.x.
PubMed 15458464Bots 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 15665029Breseghelo Mde L, Guillo LA, Nogueira TE, Leles CR. Nitric Oxide Concentration and Other Salivary Changes after Insertion of New Complete Dentures in Edentulous Subjects. Int J Dent. 2016;2016:8351427. doi: 10.1155/2016/8351427. Epub 2016 Feb 29.
PubMed 27034674Charalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16.
PubMed 28279391Cho EP, Hwang SJ, Clovis JB, Lee TY, Paik DI, Hwang YS. Enhancing the quality of life in elderly women through a programme to improve the condition of salivary hypofunction. Gerodontology. 2012 Jun;29(2):e972-80. doi: 10.1111/j.1741-2358.2011.00594.x. Epub 2011 Nov 30.
PubMed 22126433Dalodom S, Lam-Ubol A, Jeanmaneechotechai S, Takamfoo L, Intachai W, Duangchada K, Hongsachum B, Kanjanatiwat P, Vacharotayangul P, Trachootham D. Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus. Geriatr Nurs. 2016 Mar-Apr;37(2):101-9. doi: 10.1016/j.gerinurse.2015.10.014. Epub 2015 Nov 26.
PubMed 26631691Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010 Mar;39(3):477-85. doi: 10.1016/j.jpainsymman.2009.08.008.
PubMed 20303025Villa A, Wolff A, Aframian D, Vissink A, Ekstrom J, Proctor G, McGowan R, Narayana N, Aliko A, Sia YW, Joshi RK, Jensen SB, Kerr AR, Dawes C, Pedersen AM. World Workshop on Oral Medicine VI: a systematic review of medication-induced salivary gland dysfunction: prevalence, diagnosis, and treatment. Clin Oral Investig. 2015 Sep;19(7):1563-80. doi: 10.1007/s00784-015-1488-2. Epub 2015 May 22.
PubMed 25994331
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thyme Honey in Management of Xerostomia in Geriatric Patients With ESRD: Longitudinal Prospective Clinical Biochemical Study
- ClinicalTrials.gov ID
- NCT05247008
- Acronym / sponsor ID
- 972
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 18 Feb 2022 (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.
The oral health of older people has warranted considerable research attention in the last two to three decades. One of the most oral conditions that have been related to the elderly patients was xerostomia.
An elderly population that has a high rate of comorbid disease is likely to continue for the foreseeable future. Among these pathologies, End stage renal disease (ESRD) stands out as a common serious age-related disease. ESRD is a chronic irreversible renal failure. It is known also as chronic kidney disease (CKD) Stage 6 or CKD 6. Xerostomia is relatively common in patients having ESRD with prevalence ranging from 28% to 67%.
Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients with ESRD which were based on the stimulation of the salivary gland flow.
A new alternative for the control of xerostomia is the use of thyme honey, which is a propolis gel product with strong antioxidant, antibacterial, antifungal and immunomodulation effect. It is believed that the presence of honey in the oral cavity has a sialagogue effect, stimulating the salivary glands to produce more saliva, due to the high sugar concentration in honey.
The purpose of the study is to determine whether the use of thyme honey as mouth rinse will help in the treatment of xerostomia in geriatric patients with end-stage renal disease (symptom management).
Detailed description
Most patients with end-stage renal disease (ESRD) on hemodialysis (HD) have to maintain a fluid-restricted diet in order to prevent fluid overload between dialysis sessions. . However, compliance to the fluid restriction is also influenced by other factors, such as hormonal derangements, social and psychological changes, thirst and xerostomia.
Xerostomia in ESRD is a multifactorial phenomenon and various mechanisms contribute to its development as direct uremic involvement of salivary glands, atrophy and fibrosis of the salivary glands, chemical inflammation, dehydration, mouth breathing. The other conditions that may cause dry mouth in uremic patients are retrograde parotitis, metabolic abnormalities, use of diuretics and due to inability of kidneys to reabsorb sodium and the resultant polyuria.
Xerostomia, the subjective feeling of oral dryness, is a symptom most frequently accompanied by either decreased salivary flow or an altered composition of saliva. Hyposalivation, on the other hand, is the objective measured reduction in salivary flow rate. Xerostomia is a relatively common complaint, particularly among older people, and can lead to major consequences with regard to the quality of their general and oral health and wellbeing.
Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.
Secondary causes of xerostomia include the side-effects of radiation therapy or chemotherapy, rheumatoid arthritis, scleroderma, mixed connective tissues diseases, systemic lupus erythematous, graft versus host disease, anorexia, alcohol and smoking and commonly prescribed drugs (>500 medications reportedly cause dry mouth). The most common medications causing hyposalivation are those with anticholinergic activity, sympathomimetics, and benzodiazepines. The risk of xerostomia increases with the synergistic effects of xerogenic medications, multiple medications, higher doses of medication, and the duration of the medication.
Saliva plays an important role in maintaining the physiological homeostasis of the oral cavity. In addition to humidifying the oral tissues, its lubricating properties aid in swallowing and talking, and also prevent damage due to mechanical agents. Saliva contains a variety of electrolytes, peptides, glycoproteins, enzymes, immunoglobulin A, amines, and leucocytes.
Owing to the multiple functions of saliva, hyposalivation leads to speech problems, taste disorders, chewing and swallowing difficulties, ill-fitting dentures and consequently poor qualities of life. Furthermore, hyposalivation results in decreased oral clearance, declined salivary pH and buffering capacity, and reduced immune defenses. These symptoms may increase risks of developing infectious oral diseases such as cervical caries, periodontitis and oral candidiasis.
Among saliva constituents, the nitric oxide (NO) is a biochemical marker that involved in both physiological and pathological processes of the salivary glands. High concentrations of nitrate and nitrite (stable metabolites of NO) in normal saliva may ensure potentially protective effects, such as antibacterial properties, increased mucosal blood flow, and oral mucus production.
Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients with ESRD which were based on the stimulation of the salivary gland flow. Salivary glands can be stimulated to produce saliva mechanically (for example, by chewing gum, using different formulated mouthwashes or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting enzyme inhibitors and angiotensin-receptor antagonists.
Overall, the available interventions do not appear to provide an effective, comprehensive and long-term management of xerostomia. This has strengthened the need for further investigation of other interventions for the management of xerostomia.
A new alternative for the control of xerostomia is the use of thyme honey, which is a propolis gel product with strong antioxidant, antibacterial, antifungal and immunomodulation effect. It is believed that the presence of honey in the oral cavity has a sialagogue effect, stimulating the salivary glands to produce more saliva, due to the high sugar concentration in honey.
Honey has been used historically for its medicinal properties. It has been used to heal burns, surgical wounds, and oral infections because of its antibacterial and analgesic agents and epithelialization boosting effect. Honey has no side effects like other pharmaceutical drugs due to its properties.
As Egypt is considered a low-income country, therefore, the general properties of ideal saliva substitutes to be used should be inexpensive, edible, hydrating, safe-to-swallow but retainable in the mouth.
Given the importance of the oral health status of older people with ESRD associated with xerostomia and thinking that the saliva substitutes or stimulants could potentially be used to decrease this complaint, thus, the urge to drink in hemodialysis patients. This may increase compliance to the fluid-restricted diet and could, subsequently, result in improvement in their quality of life. This study is designed to evaluate the efficiency of different and natural treatment as thyme honey in management of geriatric Egyptian patients with xerostomia and its association to the level of salivary nitric oxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment protocol: * Thyme honey will topically be applied to the oral mucosa as oral rinse based on the Biswal et al. (2003) administration protocol. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse.
| Arm | Type | Receives |
|---|---|---|
| Thyme honey interventional arm in geriatric patients having end-stage renal disease. | Other | Other: Thyme honeyThyme honey used as mouth rinse in treatment of xerostomia in geriatric patients with end-stage renal disease. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both genders, of minimum 61 years.
Key exclusion criteria (6 listed)
- - Smoking, Alcohol. Healthy patients.
- Patient with history of any serious illness as malignancy, who undergo kidney transplant.
- Patients with any autoimmune disease.
- Patients with diabetes mellitus (Charalambous et al., 2017).
- Vulnerable groups such as pregnant females, 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 |
|---|---|---|
| Thyme honey* Thyme honey will topically be applied to the oral mucosa as oral rinse based on the Biswal et al. (2003) administration protocol. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. | Other | Thyme honey interventional arm in geriatric patients having end-stage renal disease. |
Primary outcome
Changes in subjective dry mouth score
Time frame: one month
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 thyme honey mouth rinse (for at least 5 days per week)
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
Changes in objective dry mouth score
Time frame: one month
Changes in salivary Potential of Hydrogen ion (pH)
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 18 Feb 2022.
- 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 12673463Biswal BM, Zakaria A, Ahmad NM. Topical application of honey in the management of radiation mucositis: a preliminary study. Support Care Cancer. 2003 Apr;11(4):242-8. doi: 10.1007/s00520-003-0443-y. Epub 2003 Feb 19.
- Background: PubMed 31117154Bossola M. Xerostomia in patients on chronic hemodialysis: An update. Semin Dial. 2019 Sep;32(5):467-474. doi: 10.1111/sdi.12821. Epub 2019 May 22.
- Background: PubMed 15458464Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Ter Wee PM, Amerongen AV. Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int. 2004 Oct;66(4):1662-8. doi: 10.1111/j.1523-1755.2004.00933.x.
- 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.
- Background: PubMed 27034674Breseghelo Mde L, Guillo LA, Nogueira TE, Leles CR. Nitric Oxide Concentration and Other Salivary Changes after Insertion of New Complete Dentures in Edentulous Subjects. Int J Dent. 2016;2016:8351427. doi: 10.1155/2016/8351427. Epub 2016 Feb 29.
- Background: PubMed 28279391Charalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16.
- Background: PubMed 22126433Cho EP, Hwang SJ, Clovis JB, Lee TY, Paik DI, Hwang YS. Enhancing the quality of life in elderly women through a programme to improve the condition of salivary hypofunction. Gerodontology. 2012 Jun;29(2):e972-80. doi: 10.1111/j.1741-2358.2011.00594.x. Epub 2011 Nov 30.
- Individual participant dataSharing planned: No. will not share my raw data
Related trials for Xerostomia
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
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 Thyme honey in people with Xerostomia, 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 7 inclusion and 6 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 18 Feb 2022. 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. 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?
Changes in subjective dry mouth score (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 NCT05247008, which also lists 22 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 18 Feb 2022.