Sore ThroatNCT06715800
Honey Against Sore Throat
A study testing Honey in people with Sore Throat and Honey, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat, Honey
- What is being tested?
- Honey
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2022to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sore Throat, Honey
- Being tested
- Honey
- Keywords
- Sore throat, Apitherapy, Functional Honey
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyDietary supplement
Also called Thyme Honey, Southeastern Anatolia, Chestnut honey, Linden honey
Functional content analyses were performed to identify the specific properties of the different types of honey used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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.. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start6 Jan 2022
- Primary completion1 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, Randomized, Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ali Timucin ATAYOGLU, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715800
- Sponsor's protocol ID
- 10840098-604.01.01-E.29934
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Relief of Sore Throat With Functional Honey: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06715800
- Acronym / sponsor ID
- 10840098-604.01.01-E.29934
- Conditions
- Sore Throat, Honey
- Keywords
- Sore throat, Apitherapy, Functional Honey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- Double blind, Randomized, Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| H1 Thyme honey group | Active comparator | Dietary Supplement: HoneyThe group who applied with the complaint of sore throat was cultured and given thyme honey in addition to drug treatment. |
| H2 Yuksekova honey group | Active comparator | Dietary Supplement: HoneyThe group who applied with the complaint of sore throat was cultured and given Yuksekova honey in addition to drug treatment. |
| H3 Chestnut honey group | Active comparator | Dietary Supplement: HoneyThe group who applied with the complaint of sore throat was cultured and given chestnut honey in addition to drug treatment.. |
| H4 Linden honey group | Active comparator | Dietary Supplement: HoneyThe group who applied with the complaint of sore throat was cultured and given linden honey in addition to drug treatment. |
| H5 Pine honey group | Active comparator | Dietary Supplement: HoneyThe group who applied with the complaint of sore throat was cultured and given pine honey in addition to drug treatment. |
| H6 Plasebo group | Placebo comparator | Dietary Supplement: HoneyThe group who applied with the complaint of sore throat was cultured and given plasebo in addition to drug treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoneyAlso: Thyme Honey, Southeastern Anatolia, Chestnut honey, Linden honeyFunctional content analyses were performed to identify the specific properties of the different types of honey used. | Dietary supplement | H1 Thyme honey group, H2 Yuksekova honey group, H3 Chestnut honey group, H4 Linden honey group, H5 Pine honey group, H6 Plasebo group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey in people with Sore Throat and Honey, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Symptome (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.