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To Check Effectiveness of Medistus Antivirus Lozenges for Cough

Primary Purpose

Throat Infection, Pharyngitis, Sore Throat

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Medistus Antivirus Lozenges
Sponsored by
Nutrin GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Throat Infection focused on measuring medistus, nutrin gmbh, throat infection, Pharyngitis, Antivirus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Arogyam Superspeciality Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention- Medistus Antivirus Lozenges

Arm Description

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

Outcomes

Primary Outcome Measures

To assess the cough episodes count
data collection on visit 2 from the subject for improvement in cough count
Throat pain assessment
on severity scale of 0-4
Redness of throat
on severity scale of 0-4
Swelling assessment
on severity scale of 0-4

Secondary Outcome Measures

Full Information

First Posted
August 21, 2020
Last Updated
October 27, 2020
Sponsor
Nutrin GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04612829
Brief Title
To Check Effectiveness of Medistus Antivirus Lozenges for Cough
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
October 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutrin GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Throat Infection, Pharyngitis, Sore Throat
Keywords
medistus, nutrin gmbh, throat infection, Pharyngitis, Antivirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention- Medistus Antivirus Lozenges
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Medistus Antivirus Lozenges
Intervention Description
A blend of Kistosyn Extract with Gum Arabic
Primary Outcome Measure Information:
Title
To assess the cough episodes count
Description
data collection on visit 2 from the subject for improvement in cough count
Time Frame
5 days
Title
Throat pain assessment
Description
on severity scale of 0-4
Time Frame
5 days
Title
Redness of throat
Description
on severity scale of 0-4
Time Frame
5 days
Title
Swelling assessment
Description
on severity scale of 0-4
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Puneet Mittal
Organizational Affiliation
Mittal Global Clinical Trial Services
Official's Role
Study Director
Facility Information:
Facility Name
Arogyam Superspeciality Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440025
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share

Learn more about this trial

To Check Effectiveness of Medistus Antivirus Lozenges for Cough

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