NCT04612829

To Check Effectiveness of Medistus Antivirus Lozenges for Cough

Completed Phase 2, PHASE3 Last updated 3 November 2020

What this trial tests

Phase 2, PHASE3 trial testing Medistus Antivirus Lozenges in Throat Infection in 30 participants. Completed in 15 October 2017.

Timeline

23 August 2017

Primary endpoint
15 October 2017

15 October 2017

Quick facts

Lead sponsor	Nutrin GmbH
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	23 August 2017
Primary completion	15 October 2017
Estimated completion	15 October 2017
Sites	1 location across India

Drugs / interventions tested

• Medistus Antivirus Lozenges

Conditions studied

• Throat Infection — all drugs for Throat Infection →
• Pharyngitis — all drugs for Pharyngitis →
• Sore Throat — all drugs for Sore Throat →

Sponsor

Nutrin GmbH

Who can join

Adults 18 to 65, any sex, with Throat Infection or Pharyngitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.