Sore ThroatEarly Phase 1NCT06811051
Effect of Clove Oil and Menthol Lozenges on Post-extubation Sore Throat
A Early Phase 1 study testing Menthol lozenge and Clove lozenge in people with Sore Throat, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial summary
In patients undergoing surgical intervention, endotracheal intubation, which is a part of the anesthesia procedure, can cause postoperative sore throat in patients. This situation causes difficulty in swallowing, inadequate nutrition and fluid intake, and prolongs the recovery process. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- Menthol lozenge and Clove lozenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Jan 2025to 15 Nov 2025
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65. Having had abdominal surgery. Being extubated within the first 8 hours after surgery. ASA class I-III. Mallampati class I-II. Glasgow Coma Scale (GCS) score 15
Who cannot join
- History of allergies.
- Severe nausea and vomiting.
- Being extubated after the first 8 hours after surgery.
- Communication disorders
- Mallampati class III-IV.
- Glasgow Coma Scale (GCS) score <15
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Atlas University
Istanbul, Kağıthane
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: Effects of Clove Oil and Menthol-containing Lozenges in Preventing Post-extubation Sore Throat in Patients Undergoing Surgical Intervention
In patients undergoing surgical intervention, endotracheal intubation, which is a part of the anesthesia procedure, can cause postoperative sore throat in patients. This situation causes difficulty in swallowing, inadequate nutrition and fluid intake, and prolongs the recovery process. In addition, sore throat is defined as a source of physical stress, which can lead to an increase in the incidence of postoperative morbidity and a decrease in patient satisfaction. This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat after surgery. Our aim was to provide evidence on the effectiveness of simple, low-cost menthol and clove oil lozenges in reducing sore throat after extubation, thus helping the patient recover.
Read the detailed description
This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat in patients after surgery.
- Conditions
- Sore Throat
- Being tested
- Menthol lozenge, Clove lozenge, None-placebo
- Keywords
- sore throat, lozenge, postoperative
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol lozengeBiological
Patients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.
Clove lozengeBiological
Patients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.
None-placeboOther
Before routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Menthol Group Patients | Experimental | Patients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out. Receives: Biological: Menthol lozenge |
| Clove lozenge group | Experimental | Patients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out. Receives: Biological: Clove lozenge |
| Control Group | Placebo comparator | Before routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated. Receives: Other: None-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain score
Sore throat pain will be measured by VAS score: zero mean NO PAIN, 10 means unsupportable pain.
Measured: Pain was assessed at 4 time points, immediately before the first application (baseline) and 30 minutes after application of each of the three lozenges (T1, T2, T3).
sore throat
VAS is used to make measurable some values that cannot be measured numerically, evaluated by individuals by marking them on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end of which indicates that the individual is "very bad".
Measured: 60 minutes after extubation
Secondary outcomes (1)
Sore throat
VAS is used to make measurable some values that cannot be measured numerically, evaluated by individuals by marking them on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end of which indicates that the individual is "very bad".
Measured: 90 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start25 Jan 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Responsible party
- Principal investigator, Cagla Toprak, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811051
- Sponsor's protocol ID
- CToprak
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clove Oil and Menthol-containing Lozenges in Preventing Post-extubation Sore Throat in Patients Undergoing Surgical Intervention
- ClinicalTrials.gov ID
- NCT06811051
- Acronym / sponsor ID
- CToprak
- Conditions
- Sore Throat
- Keywords
- sore throat, lozenge, postoperative
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 6 Feb 2025 (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.
In patients undergoing surgical intervention, endotracheal intubation, which is a part of the anesthesia procedure, can cause postoperative sore throat in patients. This situation causes difficulty in swallowing, inadequate nutrition and fluid intake, and prolongs the recovery process. In addition, sore throat is defined as a source of physical stress, which can lead to an increase in the incidence of postoperative morbidity and a decrease in patient satisfaction. This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat after surgery. Our aim was to provide evidence on the effectiveness of simple, low-cost menthol and clove oil lozenges in reducing sore throat after extubation, thus helping the patient recover.
Detailed description
This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat in patients after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menthol Group Patients | Experimental | Biological: Menthol lozengePatients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out. |
| Clove lozenge group | Experimental | Biological: Clove lozengePatients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out. |
| Control Group | Placebo comparator | Other: None-placeboBefore routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being between the ages of 18-65. Having had abdominal surgery. Being extubated within the first 8 hours after surgery. ASA class I-III. Mallampati class I-II. Glasgow Coma Scale (GCS) score 15
Key exclusion criteria (6 listed)
- History of allergies.
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 |
|---|---|---|
| Menthol lozengePatients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out. | Biological | Menthol Group Patients |
| Clove lozengePatients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out. | Biological | Clove lozenge group |
| None-placeboBefore routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated. | Other | Control Group |
Primary outcome
VAS pain score
Time frame: Pain was assessed at 4 time points, immediately before the first application (baseline) and 30 minutes after application of each of the three lozenges (T1, T2, T3).
Sore throat pain will be measured by VAS score: zero mean NO PAIN, 10 means unsupportable pain.
sore throat
Time frame: 60 minutes after extubation
VAS is used to make measurable some values that cannot be measured numerically, evaluated by individuals by marking them on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end of which indicates that the individual is "very bad".
1 secondary outcome
Sore throat
Time frame: 90 minutes after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- sore throat after extubationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Menthol lozenge and Clove lozenge in people with Sore Throat, run by Atlas University at 2 sites 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?
The sponsor lists 1 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
VAS pain score (time frame: Pain was assessed at 4 time points, immediately before the first application (baseline) and 30 minutes after application of each of the three lozenges (T1, T2, T3).). The study lists 2 primary outcomes in all. 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 6 Feb 2025.