Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Oral Mucositis

NCT06481254 | Completed

• 1 other identifier: RCS06022024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mucositis; Quality of Life

Keywords

Hawthorn vinegar; Black mulberry syrup; Mucositis; Green tea; Quality of life.

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  14 Days

Study Arms (4)

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).

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).

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).

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).

Interventions

Hawthorn Vinegar Group OTHER

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.

Hawthorn Vinegar Group

Black Mulberry Syrup Group OTHER

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.

Black Mulberry Syrup Group

Green Tea Group OTHER

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.

Green Tea Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having a known psychological disorder,
• Having HbA1c \<7%,
• Not having oral mucositis,
• Having hearing loss.

Sponsors & Collaborators

• Karadeniz Technical University: lead
• Bayburt University: collaborator

Study Sites (1)

Gümüşhane University

Gümüşhane, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hatice Demirağ, Dr.Öğr.Üyesi

  Study Principal Investigator Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigator completed the consent and assent forms after explaining the purpose of the study to all participants. In the research planned as a single-blind randomized controlled clinical study, the other researcher who applied the data collection tools to reduce bias was not told who the experimental groups (hawthorn vinegar group, black mulberry syrup group, green tea group) and the patients with DM in the control group were.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 1, 2024
• Study Start: February 6, 2024
• Primary Completion: February 13, 2024
• Study Completion: February 20, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)