Common ColdPhase 1NCT06106880
Alleviation of Common Cold Symptoms
A Phase 1 study testing Wintergreen Throat Spray and Aspirin Tablet in people with Common Cold and Pharyngitis, run by Applied Biological Laboratories Inc at 6 sites in United States.
Trial summary
Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Common Cold, Pharyngitis, Fever
- What is being tested?
- Wintergreen Throat Spray and Aspirin Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 May 2022to 16 Jun 2023
- Phase
- 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
- Otherwise healthy adults with cold symptoms including sore throat who do not meet any of the exclusion criteria listed below,
- who rate their sore throat at least a 3 on a 10-point scale,
- who have had a sore throat for less than 48 hours by the time they complete the intake clinical trial manager (CTM) assessment.
Who cannot join
- Sore throat for more than 2 full days at the time of intake CTM assessment
- Fever or development of fever during the course of the trial
- Positive COVID-19 test or influenza test at clinical trial administrator (CTA) visit
- Likelihood of strep throat (to be determined by physician PI to the best of their ability)
- Less than 2 doses of the coronavirus (COVID-19) vaccine
- Any allergies to eggs, milk, or aspirin
Show all 13Show fewer
- Females who are pregnant or test positive for pregnancy at the CTA visit
- Any chronic disease such as asthma, hypertension, post-nasal drip, gastroesophageal reflux disease (GERD), cardiopulmonary obstructive disorder (COPD), diabetes, cancer, HIV
- Any history of allergy in the last 14 days for which they took medication
- Anyone with fever above 101 or who has taken medication other than birth control in the last 30 days
- Anyone taking an Angiotensin Converting Enzyme (ACE) inhibitor
- Participation in another clinical trial within the last 6 months or during this trial
- Anyone who smokes
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Telemedicine and Home Visit
Atlanta, Georgia, 30002-0082
Telemedicine and Home Visit
Baltimore, Maryland, 21215
Telemedicine and Home Visit
Houston, Texas, 77054-3036
Telemedicine and Home Visit
Irvine, California, 92614-0120
Telemedicine and Home Visit
New York, New York, 11385
Telemedicine and Home Visit
Washington D.C., District of Columbia, 20016
About this study
Official title: Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms
Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health care system billions of dollars annually. This double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory throat sprays against placebo and against a throat spray taken in conjunction with 325mg of aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants having common cold symptoms lasting less than two days were enrolled and given treatment to administer at home. Various common cold symptoms were assessed and measured via clinically validated self-assessment scales. Participants were screened for influenza and COVID-19 before enrollment and were excluded if found positive.
- Conditions
- Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough
- Being tested
- Wintergreen Throat Spray and Aspirin Tablet, Aspirin Throat Spray and Placebo Tablet, Wintergreen Throat Spray and Placebo Tablet, Placebo Throat Spray and Placebo Tablet
- Keywords
- Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough, Sore Throat, Malaise, Headache, Runny Nose, Sneezing, Inflammation
- Medical subject headings
- Common Cold, Pharyngitis, Fever, Rhinorrhea, Cough, Headache, Sneezing, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wintergreen Throat Spray and Aspirin TabletDrug
Also called Group B
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Aspirin in a 325mg tablet
Aspirin Throat Spray and Placebo TabletDrug
Also called Group C
The liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
Wintergreen Throat Spray and Placebo TabletDietary supplement
Also called Group D
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
Placebo Throat Spray and Placebo TabletOther
Also called Group A
The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener.
The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Placebo Throat Spray and Placebo Tablet | Placebo comparator | The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. Receives: Other: Placebo Throat Spray and Placebo Tablet |
| Group B: Wintergreen Throat Spray and Aspirin Tablet | Active comparator | The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Aspirin in a 325mg tablet Receives: Drug: Wintergreen Throat Spray and Aspirin Tablet |
| Group C: Aspirin Throat Spray and Placebo Tablet | Active comparator | The liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. Receives: Drug: Aspirin Throat Spray and Placebo Tablet |
| Group D: Wintergreen Throat Spray and Placebo Tablet | Active comparator | The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. Receives: Dietary Supplement: Wintergreen Throat Spray and Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of Sore Throat Pain
A time-weighted summed difference in pain intensity on the sore throat pain intensity scale (STPIS) after the first dose of medication (STPIS 1st entry Day 1 compared to STPIS 4th entry Day 2). On the STPIS, 0mm, the leftmost point of the line, represents no throat pain, and 100mm, the rightmost point of the line, represents the most severe throat pain.
Measured: 36 hours
Secondary outcomes (1)
Clinical Efficacy Against Common Cold Symptoms
Secondary endpoints will include changes to the Modified Jackson Score, measured from Absent=0, Mild=1, Moderate=2 to Severe=3, with a higher score representing worsening of various cold symptoms and a lower score signifying improvement of various cold symptoms.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start25 May 2022
- Primary completion8 Apr 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Biological Laboratories Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Econometrica, Inc.
- Responsible party
- Sponsor
- Investigators
- Nazlie Latefi, PhD, Study director, Applied Biological Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106880
- Sponsor's protocol ID
- Pro 00048530
- Status last verified
- Jan 2024
- First submitted
- 18 Oct 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be determined as needed, if shared no identifiable personal information will be provided.
Publications
Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, Martin JM, Van Beneden C. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15;55(10):1279-82. doi: 10.1093/cid/cis847.
PubMed 23091044Kim SY, Chang YJ, Cho HM, Hwang YW, Moon YS. Non-steroidal anti-inflammatory drugs for the common cold. Cochrane Database Syst Rev. 2015 Sep 21;2015(9):CD006362. doi: 10.1002/14651858.CD006362.pub4.
PubMed 26387658Winther B, Gwaltney JM Jr, Mygind N, Turner RB, Hendley JO. Sites of rhinovirus recovery after point inoculation of the upper airway. JAMA. 1986 Oct 3;256(13):1763-7.
PubMed 3018306Rees GL, Eccles R. Sore throat following nasal and oropharyngeal bradykinin challenge. Acta Otolaryngol. 1994 May;114(3):311-4. doi: 10.3109/00016489409126062.
PubMed 8073865Proud D, Reynolds CJ, Lacapra S, Kagey-Sobotka A, Lichtenstein LM, Naclerio RM. Nasal provocation with bradykinin induces symptoms of rhinitis and a sore throat. Am Rev Respir Dis. 1988 Mar;137(3):613-6. doi: 10.1164/ajrccm/137.3.613.
PubMed 3345041Doyle WJ, Boehm S, Skoner DP. Physiologic responses to intranasal dose-response challenges with histamine, methacholine, bradykinin, and prostaglandin in adult volunteers with and without nasal allergy. J Allergy Clin Immunol. 1990 Dec;86(6 Pt 1):924-35. doi: 10.1016/s0091-6749(05)80156-3.
PubMed 2262647Gupta U, Verma M. Placebo in clinical trials. Perspect Clin Res. 2013 Jan;4(1):49-52. doi: 10.4103/2229-3485.106383. No abstract available.
PubMed 23533982Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Schachtel E. Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study. Trials. 2014 Jul 3;15:263. doi: 10.1186/1745-6215-15-263.
PubMed 24988909Glatthaar-Saalmuller B, Mair KH, Saalmuller A. Antiviral activity of aspirin against RNA viruses of the respiratory tract-an in vitro study. Influenza Other Respir Viruses. 2017 Jan;11(1):85-92. doi: 10.1111/irv.12421. Epub 2016 Sep 22.
PubMed 27542891Eccles R, Loose I, Jawad M, Nyman L. Effects of acetylsalicylic acid on sore throat pain and other pain symptoms associated with acute upper respiratory tract infection. Pain Med. 2003 Jun;4(2):118-24. doi: 10.1046/j.1526-4637.2003.03019.x.
PubMed 12873261Leyva-Grado V, Pugach P, Sadeghi-Latefi N. A novel anti-inflammatory treatment for bradykinin-induced sore throat or pharyngitis. Immun Inflamm Dis. 2021 Dec;9(4):1321-1335. doi: 10.1002/iid3.479. Epub 2021 Jun 21.
PubMed 34153179Pugach P, Sadeghi-Latefi N. Supporting respiratory epithelia and lowering inflammation to effectively treat common cold symptoms: A randomized controlled trial. PLoS One. 2024 Nov 27;19(11):e0301959. doi: 10.1371/journal.pone.0301959. eCollection 2024.
PubMed 39602479
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms
- ClinicalTrials.gov ID
- NCT06106880
- Acronym / sponsor ID
- Pro 00048530
- Conditions
- Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough
- Keywords
- Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough, Sore Throat, Malaise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Applied Biological Laboratories IncUniversity, hospital or other
- Collaborators
- Econometrica, Inc.
- Study start
- 25 May 2022 (actual)
- Primary completion
- 8 Apr 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 30 Oct 2023 (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.
Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health care system billions of dollars annually. This double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory throat sprays against placebo and against a throat spray taken in conjunction with 325mg of aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants having common cold symptoms lasting less than two days were enrolled and given treatment to administer at home. Various common cold symptoms were assessed and measured via clinically validated self-assessment scales. Participants were screened for influenza and COVID-19 before enrollment and were excluded if found positive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Placebo Throat Spray and Placebo Tablet | Placebo comparator | Other: Placebo Throat Spray and Placebo TabletThe placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
| Group B: Wintergreen Throat Spray and Aspirin Tablet | Active comparator | Drug: Wintergreen Throat Spray and Aspirin TabletThe liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet |
| Group C: Aspirin Throat Spray and Placebo Tablet | Active comparator | Drug: Aspirin Throat Spray and Placebo TabletThe liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
| Group D: Wintergreen Throat Spray and Placebo Tablet | Active comparator | Dietary Supplement: Wintergreen Throat Spray and Placebo TabletThe liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Otherwise healthy adults with cold symptoms including sore throat who do not meet any of the exclusion criteria listed below,
- who rate their sore throat at least a 3 on a 10-point scale,
- who have had a sore throat for less than 48 hours by the time they complete the intake clinical trial manager (CTM) assessment.
Key exclusion criteria (13 listed)
- Sore throat for more than 2 full days at the time of intake CTM assessment
- Fever or development of fever during the course of the trial
- Positive COVID-19 test or influenza test at clinical trial administrator (CTA) visit
- Likelihood of strep throat (to be determined by physician PI to the best of their ability)
- Less than 2 doses of the coronavirus (COVID-19) vaccine
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 |
|---|---|---|
| Wintergreen Throat Spray and Aspirin TabletAlso: Group BThe liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet | Drug | Group B: Wintergreen Throat Spray and Aspirin Tablet |
| Aspirin Throat Spray and Placebo TabletAlso: Group CThe liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. | Drug | Group C: Aspirin Throat Spray and Placebo Tablet |
| Wintergreen Throat Spray and Placebo TabletAlso: Group DThe liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients. | Dietary supplement | Group D: Wintergreen Throat Spray and Placebo Tablet |
| Placebo Throat Spray and Placebo TabletAlso: Group AThe placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients. | Other | Group A: Placebo Throat Spray and Placebo Tablet |
Primary outcome
Relief of Sore Throat Pain
Time frame: 36 hours
A time-weighted summed difference in pain intensity on the sore throat pain intensity scale (STPIS) after the first dose of medication (STPIS 1st entry Day 1 compared to STPIS 4th entry Day 2). On the STPIS, 0mm, the leftmost point of the line, represents no throat pain, and 100mm, the rightmost point of the line, represents the most severe throat pain.
1 secondary outcome
Clinical Efficacy Against Common Cold Symptoms
Time frame: 48 hours
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 16 Jan 2024.
- Background: PubMed 23091044Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, Martin JM, Van Beneden C. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15;55(10):1279-82. doi: 10.1093/cid/cis847.
- Background: PubMed 26387658Kim SY, Chang YJ, Cho HM, Hwang YW, Moon YS. Non-steroidal anti-inflammatory drugs for the common cold. Cochrane Database Syst Rev. 2015 Sep 21;2015(9):CD006362. doi: 10.1002/14651858.CD006362.pub4.
- Background: PubMed 3018306Winther B, Gwaltney JM Jr, Mygind N, Turner RB, Hendley JO. Sites of rhinovirus recovery after point inoculation of the upper airway. JAMA. 1986 Oct 3;256(13):1763-7.
- Background: PubMed 8073865Rees GL, Eccles R. Sore throat following nasal and oropharyngeal bradykinin challenge. Acta Otolaryngol. 1994 May;114(3):311-4. doi: 10.3109/00016489409126062.
- Background: PubMed 3345041Proud D, Reynolds CJ, Lacapra S, Kagey-Sobotka A, Lichtenstein LM, Naclerio RM. Nasal provocation with bradykinin induces symptoms of rhinitis and a sore throat. Am Rev Respir Dis. 1988 Mar;137(3):613-6. doi: 10.1164/ajrccm/137.3.613.
- Background: PubMed 2262647Doyle WJ, Boehm S, Skoner DP. Physiologic responses to intranasal dose-response challenges with histamine, methacholine, bradykinin, and prostaglandin in adult volunteers with and without nasal allergy. J Allergy Clin Immunol. 1990 Dec;86(6 Pt 1):924-35. doi: 10.1016/s0091-6749(05)80156-3.
- Background: PubMed 23533982Gupta U, Verma M. Placebo in clinical trials. Perspect Clin Res. 2013 Jan;4(1):49-52. doi: 10.4103/2229-3485.106383. No abstract available.
- Background: PubMed 24988909Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Schachtel E. Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study. Trials. 2014 Jul 3;15:263. doi: 10.1186/1745-6215-15-263.
- Background: PubMed 27542891Glatthaar-Saalmuller B, Mair KH, Saalmuller A. Antiviral activity of aspirin against RNA viruses of the respiratory tract-an in vitro study. Influenza Other Respir Viruses. 2017 Jan;11(1):85-92. doi: 10.1111/irv.12421. Epub 2016 Sep 22.
- Background: PubMed 12873261Eccles R, Loose I, Jawad M, Nyman L. Effects of acetylsalicylic acid on sore throat pain and other pain symptoms associated with acute upper respiratory tract infection. Pain Med. 2003 Jun;4(2):118-24. doi: 10.1046/j.1526-4637.2003.03019.x.
- Background: PubMed 34153179Leyva-Grado V, Pugach P, Sadeghi-Latefi N. A novel anti-inflammatory treatment for bradykinin-induced sore throat or pharyngitis. Immun Inflamm Dis. 2021 Dec;9(4):1321-1335. doi: 10.1002/iid3.479. Epub 2021 Jun 21.
- Derived from this study: PubMed 39602479Pugach P, Sadeghi-Latefi N. Supporting respiratory epithelia and lowering inflammation to effectively treat common cold symptoms: A randomized controlled trial. PLoS One. 2024 Nov 27;19(11):e0301959. doi: 10.1371/journal.pone.0301959. eCollection 2024.
- Individual participant dataSharing planned: Yes. Will be determined as needed, if shared no identifiable personal information will be provided.
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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.
Nazlie Latefi, PhD study director
Applied Biological Laboratories
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wintergreen Throat Spray and Aspirin Tablet in people with Common Cold and Pharyngitis, run by Applied Biological Laboratories Inc at 6 sites in United States.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Relief of Sore Throat Pain (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106880, which also lists 12 linked publications.
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 16 Jan 2024.