NCT07426198

Brief Summary

The study was conducted in intensive care units and included patients diagnosed with COPD. The study was conducted with a total of 60 COPD patients, 30 in the intervention group and 30 in the control group. Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol. The control group continued to receive standard oral care. Oral mucosa was assessed on days 1, 7 and 15.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

propolisCOPDnursingoral mucositis

Outcome Measures

Primary Outcomes (2)

  • World Health Organization Oral Mucositis Scoring Index

    The WHO Oral Mucositis Scoring Index rates the severity of mucositis on a scale of 0 to 4. Grade 0 indicates no mucositis; grade 1 indicates mild mucositis, grade 2 indicates moderate mucositis, and grades 3 and 4 indicate severe mucositis.

    The 1st, 7th, and 15th days were evaluated.

  • Oral Assessment Guide

    Each assessment area is scored on a scale of 1, 2, or 3 points based on the severity of changes in the oral mucosa. All points obtained from the eight areas are added together to calculate the Total Oral Mucosa Score (OMP). An increase in the total score indicates worsening of oral mucosal damage and associated clinical symptoms. The lowest possible score from the guide is 8, and the highest is 24.

    The 1st, 7th, and 15th days were evaluated.

Study Arms (2)

Propolis Oral Care Group

EXPERIMENTAL

Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol.

Other: Oral care with propolis

Control group

NO INTERVENTION

The control group continued to receive standard oral care.

Interventions

Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol.

Propolis Oral Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older,
  • diagnosed with COPD,
  • no oral mucositis at the start of the study,
  • no known allergy to bees or bee products,
  • able to speak and understand Turkish and communicate effectively,
  • conscious,
  • without any psychiatric illness,
  • without any mental or physical disability that would prevent them from answering questions,
  • individuals who volunteered to participate in the study were included in the study.

You may not qualify if:

  • individuals with a cancer diagnosis,
  • individuals receiving immunosuppressive therapy,
  • individuals receiving mechanical ventilation support,
  • individuals with altered consciousness or acute confusion,
  • individuals who did not volunteer to participate in the study were excluded from the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Talas, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StomatitisPulmonary Disease, Chronic Obstructive

Interventions

Propolis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
instructor

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

January 1, 2025

Primary Completion

June 10, 2025

Study Completion

June 10, 2025

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations