Health Condition 1: J00- Acute nasopharyngitis [common cold] Health Condition 2: B342- Coronavirus infection, unspecified Health Condition 3: J108- Influenza due to other identifiedinfluenza virus with other manifestations Health Condition 4: R070- Pain in throat
Conditions
Interventions
Intervention1: ANT-V Syrup: Patients will be administered 10ml of ANT-V Syrup Formulation thrice a day (TID) for 7 days.
Each 100 ml of ANT-V Syrup contains
-- Ocimum
sanctum Q -- 1ml Tinospora
cordif
Sponsors
Bhargava Phytolab Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the symptomatic relief of viral infection like common cold, flu, fever, sore throat, nasal and chest congestion etc. â?¢To evaluate the pro-inflammatory cytokine (i.e. IL-6) in the response of immunity. (Time frame:- Baseline to EOT)Timepoint: Baseline (Day 0) Day 7 (EOT Visit) Day 14 (Follow up Visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Assessment of safety and tolerability of Investigational product. I. Adverse event II. Physical examination III. Biomarker of systemic safety -Hematological test (Hemoglobin, WBC, platelet count) - Liver function test (SGOT, SGPT) - Renal function test (Serum Creatinine) -Random blood sugarTimepoint: Baseline (Day 0) Day 7 (EOT Visit) Day 14 (Follow up Visit) | — |
Countries
India
Contacts
Public ContactPragya Singh
The National Institute of Medical Sciences & Research,
Outcome results
None listed