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OpenTrials
Completed

NCT Number: NCT04612829

To Check Effectiveness of Medistus Antivirus Lozenges for Cough

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Arogyam Superspeciality Hospital

Nagpur, Maharashtra, 440025, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medistus Antivirus Lozenges

Device

A blend of Kistosyn Extract with Gum Arabic

Primary outcomes

  1. To assess the cough episodes count

    Time frame: 5 days

    data collection on visit 2 from the subject for improvement in cough count

  2. Throat pain assessment

    Time frame: 5 days

    on severity scale of 0-4

  3. Redness of throat

    Time frame: 5 days

    on severity scale of 0-4

  4. Swelling assessment

    Time frame: 5 days

    on severity scale of 0-4

Sponsors and collaborators

Lead sponsor

Nutrin GmbH

Network

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2020
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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