NCT06715800

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 29, 2024

Last Update Submit

November 29, 2024

Conditions

Keywords

Sore throatApitherapyFunctional Honey

Outcome Measures

Primary Outcomes (1)

  • Clinical Symptome

    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

Study Arms (6)

H1 Thyme honey group

ACTIVE COMPARATOR

The group who applied with the complaint of sore throat was cultured and given thyme honey in addition to drug treatment.

Dietary Supplement: Honey

H2 Yuksekova honey group

ACTIVE COMPARATOR

The group who applied with the complaint of sore throat was cultured and given Yuksekova honey in addition to drug treatment.

Dietary Supplement: Honey

H3 Chestnut honey group

ACTIVE COMPARATOR

The group who applied with the complaint of sore throat was cultured and given chestnut honey in addition to drug treatment..

Dietary Supplement: Honey

H4 Linden honey group

ACTIVE COMPARATOR

The group who applied with the complaint of sore throat was cultured and given linden honey in addition to drug treatment.

Dietary Supplement: Honey

H5 Pine honey group

ACTIVE COMPARATOR

The group who applied with the complaint of sore throat was cultured and given pine honey in addition to drug treatment.

Dietary Supplement: Honey

H6 Plasebo group

PLACEBO COMPARATOR

The group who applied with the complaint of sore throat was cultured and given plasebo in addition to drug treatment.

Dietary Supplement: Honey

Interventions

HoneyDIETARY_SUPPLEMENT

Functional content analyses were performed to identify the specific properties of the different types of honey used.

Also known as: Thyme Honey, Southeastern Anatolia, Chestnut honey, Linden honey, Pine honey, sugar syrup
H1 Thyme honey groupH2 Yuksekova honey groupH3 Chestnut honey groupH4 Linden honey groupH5 Pine honey groupH6 Plasebo group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

HoneyHigh Fructose Corn Syrup

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary SugarsDietary CarbohydratesCarbohydratesSugarsNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind, Randomized, Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 4, 2024

Study Start

January 6, 2022

Primary Completion

September 1, 2022

Study Completion

September 12, 2022

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations