XerostomiaPhase 3NCT05885906
Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics
A Phase 3 study testing Aloevera, Thyme honey and Saline in people with Xerostomia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objectives of the present study are to: 1. Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Xerostomia
- What is being tested?
- Aloevera, Thyme honey and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jul 2023to Mar 2024
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both gender, with type 2 diabetes mellitus only and suffering from xerostomia.
- Patients willing to follow all the instructions and attend all the study-associated visits.
Who cannot join
- Patients who had received radiation therapy to the head and neck region.
- Patients with other systemic diseases known to cause xerostomia (Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).
- Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.
- Patients requiring hospitalization for any medical problem during the study.
- Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.
- Vulnerable groups such as mentally or physically handicapped individuals, pregnant females, prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)
The objectives of the present study are to:
- Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective.
- Asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective.
Read more
Research question:
Which is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia?
Patient Grouping and Randomization:
Patients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. Allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1
Group 1 (Aloe Vera group)
Include (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash
Group 2 (Thyme honey group):
Include (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash
Group 3 (Saline control group):
Include (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash
Read the detailed description
Saliva is a complex mix from major as well as minor salivary glands and gingival crevicular fluids. It is a clear and slightly acidic diluted secretion with more than 99% water, electrolytes, immunoglobulins, enzymes, proteins, mucin and nitrogenous products. Subjective feeling of a dry mouth is known as xerostomia, which may result from diminished saliva production, but some people reported feeling a dry mouth even though there was no decrease in saliva quantity.Diabetes mellitus is considered one of the main causes of xerostomia There are different treatments modalities of xerostomia which include pharmacological and non-pharmacological treatments.Recently different herbs were used in the treatment of xerostomia and showed promising results and great patient acceptance among which aloe vera and thyme honey are used.
- Conditions
- Xerostomia
- Being tested
- Aloevera, Thyme honey, Saline
- Keywords
- Xerostomia, Aloevera, Thyme honey, type 2 diabetes
- Medical subject headings
- Xerostomia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AloeveraDrug
Mouthwash
Thyme honeyDrug
Mouthwash
SalineDrug
Mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Aloevera group | Active comparator | 15 patients suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash (20 ml of aloe vera 50%) 3 times per day for 4 weeks. Receives: Drug: Aloevera |
| Thyme honey group | Active comparator | 15 patients suffering from diabetes induced xerostomia that will receive thyme honey mouthwash (20 ml of thyme honey diluted in 100 ml of distilled water) 3 times per day for 4 weeks. Receives: Drug: Thyme honey |
| Saline group | Placebo comparator | 15 patients suffering from diabetes induced xerostomia that will receive saline mouthwash as a control group (20 ml of saline) 3 times per day for 4 weeks. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in unstimulated Salivary flow rate
Milliliters
Measured: Baseline, 2weeks and 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start24 Jul 2023
- Primary completionOct 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Borham Abdelhafez Abdellatif Elkhouly, Ain Shams University
- Investigators
- Radwa Rageb, PHD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885906
- Sponsor's protocol ID
- FDASU-RecIM122208
- Status last verified
- Sep 2023
- First submitted
- 22 May 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)
- ClinicalTrials.gov ID
- NCT05885906
- Acronym / sponsor ID
- FDASU-RecIM122208
- Conditions
- Xerostomia
- Keywords
- Xerostomia, Aloevera, Thyme honey, type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 2 Jun 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.
The objectives of the present study are to:
- Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective.
- Asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective.
Research question:
Which is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia?
Patient Grouping and Randomization:
Patients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. Allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1
Group 1 (Aloe Vera group)
Include (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash
Group 2 (Thyme honey group):
Include (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash
Group 3 (Saline control group):
Include (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash
Detailed description
Saliva is a complex mix from major as well as minor salivary glands and gingival crevicular fluids. It is a clear and slightly acidic diluted secretion with more than 99% water, electrolytes, immunoglobulins, enzymes, proteins, mucin and nitrogenous products. Subjective feeling of a dry mouth is known as xerostomia, which may result from diminished saliva production, but some people reported feeling a dry mouth even though there was no decrease in saliva quantity.Diabetes mellitus is considered one of the main causes of xerostomia There are different treatments modalities of xerostomia which include pharmacological and non-pharmacological treatments.Recently different herbs were used in the treatment of xerostomia and showed promising results and great patient acceptance among which aloe vera and thyme honey are used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aloevera group | Active comparator | Drug: Aloevera15 patients suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash (20 ml of aloe vera 50%) 3 times per day for 4 weeks. |
| Thyme honey group | Active comparator | Drug: Thyme honey15 patients suffering from diabetes induced xerostomia that will receive thyme honey mouthwash (20 ml of thyme honey diluted in 100 ml of distilled water) 3 times per day for 4 weeks. |
| Saline group | Placebo comparator | Drug: Saline15 patients suffering from diabetes induced xerostomia that will receive saline mouthwash as a control group (20 ml of saline) 3 times per day for 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Both gender, with type 2 diabetes mellitus only and suffering from xerostomia.
- Patients willing to follow all the instructions and attend all the study-associated visits.
Key exclusion criteria (6 listed)
- Patients who had received radiation therapy to the head and neck region.
- Patients with other systemic diseases known to cause xerostomia (Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).
- Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.
- Patients requiring hospitalization for any medical problem during the study.
- Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.
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 |
|---|---|---|
| AloeveraMouthwash | Drug | Aloevera group |
| Thyme honeyMouthwash | Drug | Thyme honey group |
| SalineMouthwash | Drug | Saline group |
Primary outcome
Change in unstimulated Salivary flow rate
Time frame: Baseline, 2weeks and 4weeks
Milliliters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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.
Radwa Rageb, PHD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aloevera, Thyme honey and Saline 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 2 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in unstimulated Salivary flow rate (time frame: Baseline, 2weeks and 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.