Honey Against Sore Throat

November 29, 2024 updated by: Ali Timucin ATAYOGLU, Medipol University

Symptomatic Relief of Sore Throat With Functional Honey: A Randomized Controlled Trial

Objective: The aim of this study is to investigate the symptomatic efficacy of oral use of different functional honeys in patients complaining of sore throat.

Materials and Methods: In the preclinical phase of the study, a total of 1000 samples of honey were examined, and the honeys were subjected to physicochemical and microbiological analyses. Based on their functional properties, five different groups of honey were determined. These are thyme honey with high antioxidant capacity, Yüksekova with high antimicrobial activity, chestnut honey with high organic acid amount, linden honey with high enzymatic and pine honey with high anti-microbial, antioxidant and phenolic compounds and enzymes. In the clinical phase of the study, patients receiving conventional treatment were randomly assigned to receive either one of five different types of honey or a honey-like food product in addition to their treatment. They were instructed to use 15 grams twice daily for 10 days. Patients were assessed on the 1st, 3rd, 7th, and 10th days for symptoms and complaints such as sore throat, difficulty swallowing, sensation of throat swelling, weakness, and fatigue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
282

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Adults presenting with sore throat symptoms due to an upper respiratory infection (URI) within the last four days were included in the study. A total of 300 patients over 18 years of age, who were prescribed necessary medication and exhibited signs and symptoms of sore throat, were enrolled.

Exclusion Criteria: Exclusion criteria included a history of diabetes, pollen or bee allergies, and aversion to honey. Participants were required not to use any additional products outside of those provided by the researchers during the study period. Written informed consent was obtained from all participants, who were then randomly assigned to either the study or control group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: H1 Thyme honey group
The group who applied with the complaint of sore throat was cultured and given thyme honey in addition to drug treatment.
Dietary supplement: Honey
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
  • Thyme Honey
  • Southeastern Anatolia
  • Chestnut honey
  • Linden honey
  • Pine honey
  • sugar syrup
Active Comparator: H2 Yuksekova honey group
The group who applied with the complaint of sore throat was cultured and given Yuksekova honey in addition to drug treatment.
Dietary supplement: Honey
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
  • Thyme Honey
  • Southeastern Anatolia
  • Chestnut honey
  • Linden honey
  • Pine honey
  • sugar syrup
Active Comparator: H3 Chestnut honey group
The group who applied with the complaint of sore throat was cultured and given chestnut honey in addition to drug treatment..
Dietary supplement: Honey
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
  • Thyme Honey
  • Southeastern Anatolia
  • Chestnut honey
  • Linden honey
  • Pine honey
  • sugar syrup
Active Comparator: H4 Linden honey group
The group who applied with the complaint of sore throat was cultured and given linden honey in addition to drug treatment.
Dietary supplement: Honey
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
  • Thyme Honey
  • Southeastern Anatolia
  • Chestnut honey
  • Linden honey
  • Pine honey
  • sugar syrup
Active Comparator: H5 Pine honey group
The group who applied with the complaint of sore throat was cultured and given pine honey in addition to drug treatment.
Dietary supplement: Honey
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
  • Thyme Honey
  • Southeastern Anatolia
  • Chestnut honey
  • Linden honey
  • Pine honey
  • sugar syrup
Placebo Comparator: H6 Plasebo group
The group who applied with the complaint of sore throat was cultured and given plasebo in addition to drug treatment.
Dietary supplement: Honey
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
  • Thyme Honey
  • Southeastern Anatolia
  • Chestnut honey
  • Linden honey
  • Pine honey
  • sugar syrup

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Symptome
Time Frame: 10 days

Symptom Evaluation: On days 3, 7, and 10, patients were assessed for throat pain, difficulty swallowing, throat swelling, and fatigue/malaise.

Throat Pain: Assessed using a Numeric Rating Scale (NRS) (0: no pain, 10: very painful).

Difficulty Swallowing: Assessed using a NRS (0: no difficulty, 10: very difficult).

Throat Swelling Sensation: Assessed using a NRS (0: no swelling, 10: severe swelling sensation).

Fatigue/Malaise: Assessed using a NRS (0: no fatigue, 10: severe fatigue).
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10840098-604.01.01-E.29934

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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