Oral MucositisNCT04118335
Mulberry Syrup on Oral Mucositis Healing
A study testing Black Mulberry Syrup in people with Oral Mucositis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD. Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Black Mulberry Syrup
- 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 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2017to 28 Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age,
- no visual or hearing problem,
- unimpaired time and place orientation,
- no psychiatric disorders,
- diagnosed with COPD,
- oral mucositis developed,
- used Nystatin and/or Benzidamine Hydrochloride therapy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Care by Black Mulberry Syrup on Oral Mucositis in Individuals With COPD
Objective: This study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.
Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.
Read the detailed description
Objective: This mix study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.
Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. Approval from the Ethics Committee and written permission from the institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.
- Conditions
- Oral Mucositis
- Being tested
- Black Mulberry Syrup
- Keywords
- Oral mucositis in COPD patients, complementary therapies, nursing interventions, oral care with black mulberry syrup
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Mulberry SyrupOther
The individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The individuals in the intervention group were asked to gargle with 5 ml black mulberry syrup three times a day after meals and wait average one minute in the mouth and then swallow, in addition to the standard practice of the clinic. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. The patients were followed for 15 days. The 15-day period is consistent with the duration of mucositis healing in the literature. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday. Receives: Other: Black Mulberry Syrup |
| Control Group | No intervention | Standard procedures of the clinic were applied to control group. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of oral mucositis healing
Oral mucosa of patients were evaluated with The Oral Evaluation Guide by examining the patients mucous membrane with the help of light source and asking patients.
Oral Evaluation Guide: The guideline evaluates the changes of the oral mucosa in eight areas. In the evaluation of the guide, numerical expressions like 1, 2, 3 are used and the changes in voice, swallowing function, saliva, tongue, lips, mucous membranes, gums, teeth or prostheses are scored. When scoring, all scores from eight areas are collected and the Oral Mucosal Score (OMS) is calculated. The lowest possible score is 8 and the highest score is 24. As the score increases, intra-oral complaints and the severity of mucositis increase.
Measured: Change from oral mucositis healing levels at 15 days
Secondary outcomes (1)
Severity of oral mucositis
Severity of oral mucositis were evaluated with World Health Organization Oral Mucositis Scoring Index by examining the patients mucous membrane with the help of light source and asking patients.
World Health Organization Oral Mucositis Scoring Index: According to this index, the severity of oral mucositis is graded as grade 0; no mucositis, grade 1; mild, grade 2; moderate, grade 3-4; severe mucositis.
Measured: Change from severity of oral mucositis at 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start9 Mar 2017
- Primary completion9 Mar 2017
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
- Investigators
- Sevda Korkut, PhD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118335
- Sponsor's protocol ID
- 2017/42
- Status last verified
- Aug 2020
- First submitted
- 3 Oct 2019
- Last updated
- 31 Aug 2020
- 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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Care by Black Mulberry Syrup on Oral Mucositis in Individuals With COPD
- ClinicalTrials.gov ID
- NCT04118335
- Acronym / sponsor ID
- 2017/42
- Conditions
- Oral Mucositis
- Keywords
- Oral mucositis in COPD patients, complementary therapies, nursing interventions, oral care with black mulberry syrup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 8 Oct 2019 (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.
Objective: This study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.
Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.
Detailed description
Objective: This mix study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.
Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. Approval from the Ethics Committee and written permission from the institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Black Mulberry SyrupThe individuals in the intervention group were asked to gargle with 5 ml black mulberry syrup three times a day after meals and wait average one minute in the mouth and then swallow, in addition to the standard practice of the clinic. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. The patients were followed for 15 days. The 15-day period is consistent with the duration of mucositis healing in the literature. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday. |
| Control Group | No intervention | –Standard procedures of the clinic were applied to control group. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- over 18 years of age,
- no visual or hearing problem,
- unimpaired time and place orientation,
- no psychiatric disorders,
- diagnosed with COPD,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Black Mulberry SyrupThe individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. | Other | Intervention Group |
Primary outcome
Duration of oral mucositis healing
Time frame: Change from oral mucositis healing levels at 15 days
Oral mucosa of patients were evaluated with The Oral Evaluation Guide by examining the patients mucous membrane with the help of light source and asking patients. Oral Evaluation Guide: The guideline evaluates the changes of the oral mucosa in eight areas. In the evaluation of the guide, numerical expressions like 1, 2, 3 are used and the changes in voice, swallowing function, saliva, tongue, lips, mucous membranes, gums, teeth or prostheses are scored. When scoring, all scores from eight areas are collected and the Oral Mucosal Score (OMS) is calculated. The lowest possible score is 8 and the highest score is 24. As the score increases, intra-oral complaints and the severity of mucositis increase.
1 secondary outcome
Severity of oral mucositis
Time frame: Change from severity of oral mucositis at 15 days
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 31 Aug 2020.
- 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.
Sevda Korkut, PhD principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Mulberry Syrup in people with Oral Mucositis, run by TC Erciyes 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 1 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 31 Aug 2020. 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?
Duration of oral mucositis healing (time frame: Change from oral mucositis healing levels at 15 days). 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 31 Aug 2020.