Comparator study with Standard of care treatment and Investigational product (HAVR-122008) in Uncomplicated Respiratory Viral Infection.
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2021/03/032446
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects of either gender aged more than >18 â?? <65 years.
2.Subjects suffering from acute respiratory illness with one or more signs and symptoms consistent with a viral infection (eg. fever, headache, nasal discharge, fatigue, sore throat, sneezing, cough, sleep disturbance, muscle or body aches etc)
3.Onset of symptoms within 3 days from the anticipated time of randomization. Onset of symptoms is defined as the time the subject becomes aware of the first sign and/or symptom consistent with a viral infection.
4.Subject must be medically stable on the basis of physical examination, medical history and vital signs performed at screening.
5.Ability to understand and willing to give a written informed consent prior to any study-related procedures and ready to follow and in agreement to visits as per the study assessment visits
6.Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 15 days following completion of therapy.
1.Subjects with opportunistic infections / severe infections requiring of Anti-viral / Anti-Bacterial medication at screening.
2. Hospitalized subjects or subjects expected to be hospitalized during the study duration.
3.Individuals with acute respiratory distress.
4.Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/renal/liver diseases
5.Subjects with known hypersensitivity to any of the test materials or related compounds.
6. Subjects who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
7. Subject with a history of known or suspected chronic or acute hepatitis B or C infection
8.Women who are pregnant or breastfeeding
9.Pre-existing systemic disease necessitating long-term medications.
10.Genetic and endocrinal disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method