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Mulberry Syrup on Oral Mucositis Healing

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Black Mulberry Syrup
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring Oral mucositis in COPD patients, complementary therapies, nursing interventions, oral care with black mulberry syrup

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Sites / Locations

  • Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 3, 2019
Last Updated
August 28, 2020
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT04118335
Brief Title
Mulberry Syrup on Oral Mucositis Healing
Official Title
The Effect of Oral Care by Black Mulberry Syrup on Oral Mucositis in Individuals With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Oral mucositis in COPD patients, complementary therapies, nursing interventions, oral care with black mulberry syrup

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Black Mulberry Syrup
Intervention Description
The individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it.
Primary Outcome Measure Information:
Title
Duration of oral mucositis healing
Description
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.
Time Frame
Change from oral mucositis healing levels at 15 days
Secondary Outcome Measure Information:
Title
Severity of oral mucositis
Description
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.
Time Frame
Change from severity of oral mucositis at 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevda Korkut, PhD
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Mulberry Syrup on Oral Mucositis Healing

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