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To Check Effectiveness of Medistus Antivirus Lozenges for Cough

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.

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04612829
Enrollment
30
Registered
2020-11-03
Start date
2017-08-23
Completion date
2017-10-15
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis, Sore Throat, Throat Infection

Keywords

medistus, nutrin gmbh, throat infection, Pharyngitis, Antivirus

Brief 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. 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.

Interventions

DEVICEMedistus Antivirus Lozenges

A blend of Kistosyn Extract with Gum Arabic

Sponsors

Nutrin GmbH
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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) * 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)

Design outcomes

Primary

MeasureTime frameDescription
To assess the cough episodes count5 daysdata collection on visit 2 from the subject for improvement in cough count
Throat pain assessment5 dayson severity scale of 0-4
Redness of throat5 dayson severity scale of 0-4
Swelling assessment5 dayson severity scale of 0-4

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026