To Evaluate the Efficacy and Safety of ANT-V Syrup to show antiviral action of upper respiratorytract like common cold and act as an immune booster to fight against infection, flu, fever, sorethroat, nasal and chest congestion Breathlessness in COVID-19 patients.
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]Health Condition 2: B342- Coronavirus infection, unspecifiedHealth Condition 3: J108- Influenza due to other identifiedinfluenza virus with other manifestationsHealth Condition 4: R070- Pain in throat
- Registration Number
- CTRI/2020/11/028897
- Lead Sponsor
- Bhargava Phytolab Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or Female having the age of 18 to 55 years.
-Presented symptoms of recent onset, for more than 6 hours and
less than 72 hours, characterizing one of the following conditions:
The viral infection on upper respiratory tract like common cold, which
consists of at least 2 symptoms among the 10 following- sneezing,
rhinorrhea, nasal congestion, headache, muscle pain, discomfort in
the throat, sore throat, dysphonia/congestion of chest, cough, fever,
fatigue, the latter being of moderate to severe intensity through a
symptom severity scale of 4 points (0 none, 1 mild, 2 moderate, 3
severe)
-The flu syndrome, which consists of fever of at least 101. F and
headache of moderate or severe intensity or myalgia / arthralgia
moderate or severe using a scale of severity of symptoms of 4 points
(0 none, 1 mild, 2 moderate, 3 severe)
-Willing to provide written informed consent for participation in the
study and adhere to the protocol requirements.
-Patients who are not willing to give written informed consent.
-Any known hypersensitivity to the study products.
-Pregnant and lactating women.
-Patients who have taken treatment for the presenting symptom
within 7 days of screening.
-Any history of drug abuse /chronic alcoholism
-Patients who received influenza vaccine within 7 days of screening.
-Patients who in the opinion of attending physician may require
antibiotic treatment.
-Participation in any clinical trials prior to 12 months.
-Severely immune compromised patients and who is on
immunosuppressant and anti-viral medication.
-Patients with positive serology laboratory values.
-Use of any investigational drug currently or within 30 days prior to
study entry.
-Subjects on any prescription medication that might interfere with
study outcomes.
-Patients with severe hepatic, renal insufficiency.
-History of alcohol or drug abuse.
-Patient with any underlying disease like diabetes, asthma, heart
disease, cancer, HIV or any other.
-Recent Heart surgery, on medication post-surgery.
-Allergic to a similar drug or ingredients in the drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the symptomatic relief of viral infection <br/ ><br>like common cold, flu, fever, sore throat, nasal <br/ ><br>and chest congestion etc. <br/ ><br>â?¢To evaluate the pro-inflammatory cytokine (i.e. <br/ ><br>IL-6) in the response of immunity. (Time frame:- <br/ ><br>Baseline to EOT)Timepoint: Baseline (Day 0) <br/ ><br>Day 7 (EOT Visit) <br/ ><br>Day 14 (Follow up Visit)
- Secondary Outcome Measures
Name Time Method â?¢Assessment of safety and tolerability of <br/ ><br>Investigational product. <br/ ><br>I. Adverse event <br/ ><br>II. Physical examination <br/ ><br>III. Biomarker of systemic safety <br/ ><br>-Hematological test (Hemoglobin, WBC, platelet <br/ ><br>count) <br/ ><br>- Liver function test (SGOT, SGPT) <br/ ><br>- Renal function test (Serum Creatinine) <br/ ><br>-Random blood sugarTimepoint: Baseline (Day 0) <br/ ><br>Day 7 (EOT Visit) <br/ ><br>Day 14 (Follow up Visit)