Status:
COMPLETED
Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
Lead Sponsor:
Joint Stock Company "Farmak"
Conditions:
Acute Respiratory Viral Infections
Human Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
This randomized, single blind clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the treatment of patien...
Detailed Description
Numerous studies have shown that influenza vaccines, prepared against the relevant epidemic seasonal vaccine strains, are an effective remedy in prevention of this mass disease and are able to protect...
Eligibility Criteria
Inclusion
- Patients aged between 18 to 60 years
- Patients with ARVI, including influenza, starting not later than for 1 day prior to inclusion in the study:
- The body temperature measured axillary above 37.2 °C
- Presence of one of the signs of respiratory disease (runny nose, cough, pain / tickling in the throat)
- Presence of one of the systemic symptoms (weakness, myalgia, headache , chills, sweating)
- Provide written informed consent
- Ability to understand the nature of the study and provide written informed consent in accordance with Good Clinical Practice (GCP) and local law
Exclusion
- Age over 60 years and under 18 years old
- Presence of allergic reactions
- Intolerance to NSAIDs and iodine-containing drugs
- Hypersensitivity to the components of the drug
- Mental illness that impedes compliance with the research procedure
- Pregnancy or breast-feeding
- Presence of acute, clinically significant respiratory and cardio vascular insufficiency, functional disorders of liver, kidney, digestive tract (ulcer disease) determined at physical examination or by laboratory screening tests
- Presence of congenital defects or serious chronic disease of the lungs, kidneys, cardiovascular system, nervous system, metabolic disorders, psychiatric disorders, confirmed by patients history or during initial examination
- The use of preparations of blood cytokine immunoglobulin in for 3 months prior to the study
- Chronic use of alcohol and / or drugs
- Presence or history of cancer diseases, HIV, hepatitis B and C
- Application of immunosuppressive or immunomodulatory drugs for 6-months prior to the study
- Women of child-bearing potential and who do not use acceptable measure of contraception or do not plan to use those throughout the study
- Any clinical condition that, according to the investigator, will not allow to safely carry out the protocol and take the studied drugs without risk to health
- Patients receiving antiviral therapy,
- Participation in other clinical trials at the present time or during the last 3 months.
Key Trial Info
Start Date :
April 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04682444
Start Date
April 13 2009
End Date
January 15 2010
Last Update
January 8 2026
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