MucositisOral MucositisNCT06481254
Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Oral Mucositis
A study testing Hawthorn Vinegar Group, Black Mulberry Syrup Group and Green Tea Group in people with Mucositis and Quality of Life, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucositis, Quality of Life
- What is being tested?
- Hawthorn Vinegar Group, Black Mulberry Syrup Group and Green Tea Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2024to 20 Feb 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overs 18 years of age,
- Voluntary participation in the study,
- Be lucid and able to communicate,
- Be diagnosed with DM for at least 3 months ago,
- Willing to use either hawthorn vinegar, black mulberry syrup or green tea as a complementary treatment for oral mucositis,
- HbA1c ≥ 7% (Wang and Hng, 2021),
- Oral mucositis score of 14< in oral assessment.
Who cannot join
- Having a known psychological disorder,
- Having HbA1c <7%,
- Not having oral mucositis,
- Having hearing loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Quality of Life Related to Oral Mucositis and Oral Health in Individuals With Diabetes: Single Blind Randomized Controlled Study
In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.
Read the detailed description
Diabetes Mellitus (DM) is a chronic metabolic disease that causes serious damage to the heart, blood vessels, eyes, kidneys and nerves. Both the number of cases and the prevalence of diabetes have been increased rapidly over the past 30 years. According to the report of the International Diabetes Federation (IDF) Report, approximately 537 million people worldwide (700 million in 4045) have diabetes and 6.5 million people were reported to have died due to diabetes in 2021. In Turkey, it is estimated that approximately 9 million people (about 13.5 million in 2045) are diagnosed with diabetes and approximately 80 thousand people will die from diabetes.
Prolonged hyperglycemia in DM can lead to microvascular (nephropathy, retinopathy and neuropathy) and macrovascular (peripheral vascular disease, hypertension, cerebrovascular disease, ischaemic heart disease) complications. However, due to poorly controlled DM, complications can be seen in the oral mucosa of patients with many immunological and metabolic changes. Oral complications seen in patients with DM include hyposalivation, xerostomia, bacterial, viral and fungal infections, poor wound healing, increased severity and incidence of caries, gingivitis and periodontal disease, periapical abscess, and burning mouth syndrome (BMS). These complications can lead to the development of oral mucositis in patients.
Many pharmacological and non-pharmacological agents are used in the prevention/treatment of oral mucositis. According to the classification of the National Center for Complementary and Integrative Health (NCCAM), complementary therapies methods are divided into three groups as nutritional, psychological and physiological and other complementary approaches. However, it is reported in the literature that complementary therapies such as cryotherapy (oral cooling), honey, propolis, vitamin E, selenium, aloe vera, black mulberry, apple cider vinegar, rose water and green tea are effective in the treatment of oral mucositis. Again in the literature, there are studies in which the effect of black mulberry syrup in patients with Chronic Obstructive Pulmonary Disease (COPD), apple cider vinegar and rose water mixture in cancer patients and green tea in the treatment of oral mucositis has been proven.
Oral mucositis is one of the oral diseases that can cause oral dysfunction, dysphagia and reduced oral health-related quality of life in patients. Oral and dental health affects a person's quality of life by affecting their physiological, psychological and social functioning. However, improving oral health is part of nursing care. In order to maintain a good quality of life, it is necessary to improve awareness of oral complications that occur in patients with DM. In the literature reviewed, only one experimental study was found in cancer patients in which oral mucositis-related quality of life was evaluated. There is no international or Turkish study on the treatment of oral mucositis in patients with DM. There are also no studies comparing hawthorn vinegar, black mulberry syrup and green tea in different sample groups. In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.
- Conditions
- Mucositis, Quality of Life
- Being tested
- Hawthorn Vinegar Group, Black Mulberry Syrup Group, Green Tea Group
- Keywords
- Hawthorn vinegar, Black mulberry syrup, Mucositis, Green tea, Quality of life.
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hawthorn Vinegar GroupOther
To routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days.
Black Mulberry Syrup GroupOther
To routine oral mucositis treatment, patients with DM in the black mulberry syrup group pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days.
Green Tea GroupOther
To routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Hawthorn Vinegar Group | Experimental | Before starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test). Receives: Other: Hawthorn Vinegar Group |
| Black Mulberry Syrup Group | Experimental | Before starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the black mulberry syrup group gargled with 1 tablespoon (10 cc) of pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test). Receives: Other: Black Mulberry Syrup Group |
| Green Tea Group | Experimental | Before starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test). Receives: Other: Green Tea Group |
| Control Group | No intervention | Patients in the control group received no any treatment other than routine oral mucositis treatment and data collection tools. "Patient Information Form", "OAG" and "OHQoL-UK" were administered to the patients before the study (pre-test/0th week) and "OAG" and "OHQoL-UK" were administered again on the 7th day (mid-measurement) and 14th day/end of the study (post-test). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Assessment Guide (OAG)
The "OAG" is useful for assessing and recording the individual's daily oral condition, as well as detecting the presence of mucositis and evaluating the effectiveness of treatment. The "OAG" consists of 8 categories including voice, dysphagia, lips, tongue, saliva, mucous membranes, gums and teeth/prostheses.
"OAG" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).
Measured: 14 Days
Oral Health Related Quality of Life Scale (OHQoL-UK)
The 5-point Likert-type scale, which consists of a total of 16 items to determine the degree of impact of teeth, gums, mouth or prosthesis, consists of 4 dimensions: "symptom" (items 1-2), "physical condition" (items 3-7), "psychological condition" (items 8-12) and "social condition" (items 13-16). Each item in the scale is scored as "Very bad effect-1, bad effect-2, no effect-3, good effect-4, very good effect-5". The total score of the scale varies between 16-80, and a high score indicates a high level of oral and dental health-related quality of life. The Cronbach alpha value of the scale was reported as 0.94.
"OHQoL-UK" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start6 Feb 2024
- Primary completion13 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MucositisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size of the study was calculated as 128 individuals in total (32 for each group) for 4 groups (hawthorn vinegar, black mulberry syrup, green tea, control group) with an effect size of 0.25 with α=0.05 and the power of the targeted test was 0.80 (80%) in the G\*Power 3.1.9.7 program, which could not be used as a reference since there was no previous four-group study on the subject. Each group was increased to account for drop-outs and deaths and a total of 140 individuals, 35 for each group, were included in the study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayburt University
- Responsible party
- Principal investigator, Hatice Demirağ, Ph.D, Gümüşhane Universıty
- Investigators
- Hatice Demirağ, Dr.Öğr.Üyesi, Principal investigator, Study Principal Investigator Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481254
- Sponsor's protocol ID
- RCS06022024
- Acronym
- Oral Mucositis
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demirag H, Akeren Z. The effect of hawthorn vinegar, black mulberry syrup, and green tea on oral mucositis and oral health-related quality of life in individuals with diabetes: a single-blind, randomized controlled trial. Front Med (Lausanne). 2026 Aug 20;13:1841943. doi: 10.3389/fmed.2026.1841943. eCollection 2026.
PubMed 42694165
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Quality of Life Related to Oral Mucositis and Oral Health in Individuals With Diabetes: Single Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06481254
- Acronym / sponsor ID
- Oral Mucositis / RCS06022024
- Conditions
- Mucositis, Quality of Life
- Keywords
- Hawthorn vinegar, Black mulberry syrup, Mucositis, Green tea, Quality of life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Collaborators
- Bayburt University
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 1 Jul 2024 (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.
In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.
Detailed description
Diabetes Mellitus (DM) is a chronic metabolic disease that causes serious damage to the heart, blood vessels, eyes, kidneys and nerves. Both the number of cases and the prevalence of diabetes have been increased rapidly over the past 30 years. According to the report of the International Diabetes Federation (IDF) Report, approximately 537 million people worldwide (700 million in 4045) have diabetes and 6.5 million people were reported to have died due to diabetes in 2021. In Turkey, it is estimated that approximately 9 million people (about 13.5 million in 2045) are diagnosed with diabetes and approximately 80 thousand people will die from diabetes.
Prolonged hyperglycemia in DM can lead to microvascular (nephropathy, retinopathy and neuropathy) and macrovascular (peripheral vascular disease, hypertension, cerebrovascular disease, ischaemic heart disease) complications. However, due to poorly controlled DM, complications can be seen in the oral mucosa of patients with many immunological and metabolic changes. Oral complications seen in patients with DM include hyposalivation, xerostomia, bacterial, viral and fungal infections, poor wound healing, increased severity and incidence of caries, gingivitis and periodontal disease, periapical abscess, and burning mouth syndrome (BMS). These complications can lead to the development of oral mucositis in patients.
Many pharmacological and non-pharmacological agents are used in the prevention/treatment of oral mucositis. According to the classification of the National Center for Complementary and Integrative Health (NCCAM), complementary therapies methods are divided into three groups as nutritional, psychological and physiological and other complementary approaches. However, it is reported in the literature that complementary therapies such as cryotherapy (oral cooling), honey, propolis, vitamin E, selenium, aloe vera, black mulberry, apple cider vinegar, rose water and green tea are effective in the treatment of oral mucositis. Again in the literature, there are studies in which the effect of black mulberry syrup in patients with Chronic Obstructive Pulmonary Disease (COPD), apple cider vinegar and rose water mixture in cancer patients and green tea in the treatment of oral mucositis has been proven.
Oral mucositis is one of the oral diseases that can cause oral dysfunction, dysphagia and reduced oral health-related quality of life in patients. Oral and dental health affects a person's quality of life by affecting their physiological, psychological and social functioning. However, improving oral health is part of nursing care. In order to maintain a good quality of life, it is necessary to improve awareness of oral complications that occur in patients with DM. In the literature reviewed, only one experimental study was found in cancer patients in which oral mucositis-related quality of life was evaluated. There is no international or Turkish study on the treatment of oral mucositis in patients with DM. There are also no studies comparing hawthorn vinegar, black mulberry syrup and green tea in different sample groups. In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- The sample size of the study was calculated as 128 individuals in total (32 for each group) for 4 groups (hawthorn vinegar, black mulberry syrup, green tea, control group) with an effect size of 0.25 with α=0.05 and the power of the targeted test was 0.80 (80%) in the G*Power 3.1.9.7 program, which could not be used as a reference since there was no previous four-group study on the subject. Each group was increased to account for drop-outs and deaths and a total of 140 individuals, 35 for each group, were included in the study
| Arm | Type | Receives |
|---|---|---|
| Hawthorn Vinegar Group | Experimental | Other: Hawthorn Vinegar GroupBefore starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test). |
| Black Mulberry Syrup Group | Experimental | Other: Black Mulberry Syrup GroupBefore starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the black mulberry syrup group gargled with 1 tablespoon (10 cc) of pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test). |
| Green Tea Group | Experimental | Other: Green Tea GroupBefore starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test). |
| Control Group | No intervention | –Patients in the control group received no any treatment other than routine oral mucositis treatment and data collection tools. "Patient Information Form", "OAG" and "OHQoL-UK" were administered to the patients before the study (pre-test/0th week) and "OAG" and "OHQoL-UK" were administered again on the 7th day (mid-measurement) and 14th day/end of the study (post-test). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Overs 18 years of age,
- Voluntary participation in the study,
- Be lucid and able to communicate,
- Be diagnosed with DM for at least 3 months ago,
- Willing to use either hawthorn vinegar, black mulberry syrup or green tea as a complementary treatment for oral mucositis,
Key exclusion criteria (4 listed)
- Having a known psychological disorder,
- Having HbA1c <7%,
- Not having oral mucositis,
- Having hearing loss.
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 |
|---|---|---|
| Hawthorn Vinegar GroupTo routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days. | Other | Hawthorn Vinegar Group |
| Black Mulberry Syrup GroupTo routine oral mucositis treatment, patients with DM in the black mulberry syrup group pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days. | Other | Black Mulberry Syrup Group |
| Green Tea GroupTo routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days. | Other | Green Tea Group |
Primary outcome
Oral Assessment Guide (OAG)
Time frame: 14 Days
The "OAG" is useful for assessing and recording the individual's daily oral condition, as well as detecting the presence of mucositis and evaluating the effectiveness of treatment. The "OAG" consists of 8 categories including voice, dysphagia, lips, tongue, saliva, mucous membranes, gums and teeth/prostheses. "OAG" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).
Oral Health Related Quality of Life Scale (OHQoL-UK)
Time frame: 14 Days
The 5-point Likert-type scale, which consists of a total of 16 items to determine the degree of impact of teeth, gums, mouth or prosthesis, consists of 4 dimensions: "symptom" (items 1-2), "physical condition" (items 3-7), "psychological condition" (items 8-12) and "social condition" (items 13-16). Each item in the scale is scored as "Very bad effect-1, bad effect-2, no effect-3, good effect-4, very good effect-5". The total score of the scale varies between 16-80, and a high score indicates a high level of oral and dental health-related quality of life. The Cronbach alpha value of the scale was reported as 0.94. "OHQoL-UK" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).
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 Nov 2025.
- Derived from this study: PubMed 42694165Demirag H, Akeren Z. The effect of hawthorn vinegar, black mulberry syrup, and green tea on oral mucositis and oral health-related quality of life in individuals with diabetes: a single-blind, randomized controlled trial. Front Med (Lausanne). 2026 Aug 20;13:1841943. doi: 10.3389/fmed.2026.1841943. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Hatice Demirağ, Dr.Öğr.Üyesi principal investigator
Study Principal Investigator Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hawthorn Vinegar Group, Black Mulberry Syrup Group and Green Tea Group in people with Mucositis and Quality of Life, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 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 18 Nov 2025. 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 Turkey (Türkiye). 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?
Oral Assessment Guide (OAG) (time frame: 14 Days). The study lists 2 primary outcomes in all. 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 NCT06481254, which also lists 1 linked publication.
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 Nov 2025.