Throat InfectionPhase 2/3NCT04612829
To Check Effectiveness of Medistus Antivirus Lozenges for Cough
A Phase 2/3 study testing Medistus Antivirus Lozenges in people with Throat Infection and Pharyngitis, run by Nutrin GmbH at 1 site in India.
Trial summary
A thraot infection sometimes called pharyngitis can be either a bacterial or a viral infection leading to inflammation of the tissues of the throat that causes redness, pain and swelling of the walls and structure of the throat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Throat Infection, Pharyngitis, Sore Throat
- What is being tested?
- Medistus Antivirus Lozenges
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 23 Aug 2017to 15 Oct 2017
- Phase
- Phase 2/3
- 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
- Patient with mild to moderate acute Pharyngitis or sore throat or strep throat
- Voluntarily signed informed consent for participation in this clinical study
- Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary.
Who cannot join
- Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- Oro-pharyngeal paresthesia or mycosis
- Severely traumatised and/or very severe oromucosal inflammation
- Tonsillopharyngectomy
- Peritonsillar abscess
- Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs(NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
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- Any anti-inflammatory drugs intake by systemic route within 12 hours before assigning
- Any paracetamol intake within 6 hours before randomisation
- Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
- Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before recruitment
- Heavy smokers (>20 cigarettes/day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Randomized, Active Controlled, Single Arm, Study to Ensure the Efficacy and Safety of Medistus Antivirus Lozenges in Mild to Moderate Acute Pharyngitis or Sore Throat or Strep Throat.
A thraot infection sometimes called pharyngitis can be either a bacterial or a viral infection leading to inflammation of the tissues of the throat that causes redness, pain and swelling of the walls and structure of the throat.
The throat or Pharynx is the tube like structure that carries both food to the oesophagus and air to your wind pipe (called the larynx). Infective agents of the throat most often enters through the month or nose. Many of these infections are viral, other can be caused by bacteria such as Streptococcus Pyogenes, or Group A streptococcus.
Read more
Symtoms of throat infections most commonly includes pain and a sensation of heat in the throat or Pharynx.
Viral infections accounts for approx. 70% of all pharyngitis. Rhinovirus is the most common cause of viral infections. The other common causes of viral infections in descending order are corona virus, adeno virus, para influenza, and influenza virus. Viral infections are more common during the winter month with the exception of adeno viruses which occur year round.
Viral Pharyngitis is spread through similar mechanism as other viral infections. Hand to mouth contact, contact with oral secretions, and sharing common utensils, all contributes to viral spread.
Prevention of the spread of diseases is based on frequent hand washing, and clinical symptoms of different viruses are more prevalent during certain seasons. Coryza, conjectivitis, malease, or fatigue, hoarseness, and low grade fever such as the presence of viral phayngitis. Subjects with viral pharyngitis can also have atypical symptoms such as mouth breathing, nausea, abdominal pain, and diarrhoea.
Medistus Antivirus is a medical device product with a noble impact. Kistosyn 100 extract contains polyphenols, and with the help of gum arabic, it forms a protective film over the mouth and throat mucus membranes. This protective Barrier lead to a physical (mechanical) barrier against viruses and bacteria which prevent their penetration into body cells, and their further propagation. Due to this physical effect, resistance development is not possible.
- Conditions
- Throat Infection, Pharyngitis, Sore Throat
- Being tested
- Medistus Antivirus Lozenges
- Keywords
- medistus, nutrin gmbh, throat infection, Pharyngitis, Antivirus
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medistus Antivirus LozengesDevice
A blend of Kistosyn Extract with Gum Arabic
| Study group | Role | What they receive |
|---|---|---|
| Intervention- Medistus Antivirus Lozenges | Experimental | A blend of Kistosyn Extract with Gum Arabic 1 Lozenge after every 2 hours, 5 times a day. Mode of Administration: Oral Duration of Treatment: 5 days Receives: Device: Medistus Antivirus Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the cough episodes count
data collection on visit 2 from the subject for improvement in cough count
Measured: 5 days
Throat pain assessment
on severity scale of 0-4
Measured: 5 days
Redness of throat
on severity scale of 0-4
Measured: 5 days
Swelling assessment
on severity scale of 0-4
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start23 Aug 2017
- Primary completion15 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Throat InfectionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrin GmbH
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Puneet Mittal, Study director, Mittal Global Clinical Trial Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612829
- Sponsor's protocol ID
- NUTRIN002
- Status last verified
- Oct 2020
- First submitted
- 21 Aug 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Active Controlled, Single Arm, Study to Ensure the Efficacy and Safety of Medistus Antivirus Lozenges in Mild to Moderate Acute Pharyngitis or Sore Throat or Strep Throat.
- ClinicalTrials.gov ID
- NCT04612829
- Acronym / sponsor ID
- NUTRIN002
- Conditions
- Throat Infection, Pharyngitis, Sore Throat
- Keywords
- medistus, nutrin gmbh, throat infection, Pharyngitis, Antivirus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nutrin GmbHResearch network
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 3 Nov 2020 (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.
A thraot infection sometimes called pharyngitis can be either a bacterial or a viral infection leading to inflammation of the tissues of the throat that causes redness, pain and swelling of the walls and structure of the throat.
The throat or Pharynx is the tube like structure that carries both food to the oesophagus and air to your wind pipe (called the larynx). Infective agents of the throat most often enters through the month or nose. Many of these infections are viral, other can be caused by bacteria such as Streptococcus Pyogenes, or Group A streptococcus.
Symtoms of throat infections most commonly includes pain and a sensation of heat in the throat or Pharynx.
Viral infections accounts for approx. 70% of all pharyngitis. Rhinovirus is the most common cause of viral infections. The other common causes of viral infections in descending order are corona virus, adeno virus, para influenza, and influenza virus. Viral infections are more common during the winter month with the exception of adeno viruses which occur year round.
Viral Pharyngitis is spread through similar mechanism as other viral infections. Hand to mouth contact, contact with oral secretions, and sharing common utensils, all contributes to viral spread.
Prevention of the spread of diseases is based on frequent hand washing, and clinical symptoms of different viruses are more prevalent during certain seasons. Coryza, conjectivitis, malease, or fatigue, hoarseness, and low grade fever such as the presence of viral phayngitis. Subjects with viral pharyngitis can also have atypical symptoms such as mouth breathing, nausea, abdominal pain, and diarrhoea.
Medistus Antivirus is a medical device product with a noble impact. Kistosyn 100 extract contains polyphenols, and with the help of gum arabic, it forms a protective film over the mouth and throat mucus membranes. This protective Barrier lead to a physical (mechanical) barrier against viruses and bacteria which prevent their penetration into body cells, and their further propagation. Due to this physical effect, resistance development is not possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention- Medistus Antivirus Lozenges | Experimental | Device: Medistus Antivirus LozengesA blend of Kistosyn Extract with Gum Arabic 1 Lozenge after every 2 hours, 5 times a day. Mode of Administration: Oral Duration of Treatment: 5 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with mild to moderate acute Pharyngitis or sore throat or strep throat
- Voluntarily signed informed consent for participation in this clinical study
- Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary.
Key exclusion criteria (11 listed)
- Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- Oro-pharyngeal paresthesia or mycosis
- Severely traumatised and/or very severe oromucosal inflammation
- Tonsillopharyngectomy
- Peritonsillar abscess
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 |
|---|---|---|
| Medistus Antivirus LozengesA blend of Kistosyn Extract with Gum Arabic | Device | Intervention- Medistus Antivirus Lozenges |
Primary outcome
To assess the cough episodes count
Time frame: 5 days
data collection on visit 2 from the subject for improvement in cough count
Throat pain assessment
Time frame: 5 days
on severity scale of 0-4
Redness of throat
Time frame: 5 days
on severity scale of 0-4
Swelling assessment
Time frame: 5 days
on severity scale of 0-4
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 3 Nov 2020.
- Individual participant dataSharing planned: No. No plan to share
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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.
Puneet Mittal study director
Mittal Global Clinical Trial Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Medistus Antivirus Lozenges in people with Throat Infection and Pharyngitis, run by Nutrin GmbH at 1 site in India.
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 11 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 3 Nov 2020. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the cough episodes count (time frame: 5 days). The study lists 4 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 3 Nov 2020.