CTRI/2020/11/028897尚未招募3 期
A Prospective, Interventional, Randomized, Double blind, placebo Controlled, Clinical Study to Evaluate the Efficacy and Safety of ANT-V Syrup of Bhargava Phytolab Pvt. Ltd., to show antiviral action against Covid-19 (Asymptomatic and mild cases) and act as immune booster to fight against infection, flu, fever, sore throat, nasal and chest congestion and breathlessness
Bhargava Phytolab Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •-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.
排除标准
- •-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.
研究者
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