- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06715800
Honey Against Sore Throat
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34810
- Istanbul Medipol University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
|
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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.
|
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
|
|
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..
|
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
|
|
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.
|
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
|
|
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.
|
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
|
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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.
|
Functional content analyses were performed to identify the specific properties of the different types of honey used.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.29934
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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