STUDY to understand the effect and tolerance of Experimental product in patient with UPPER RESPIRATORY TRACT INFECTIONS (URTI)
- Conditions
- Health Condition 1: J069- Acute upper respiratory infection,unspecified
- Registration Number
- CTRI/2021/09/036807
- Lead Sponsor
- Vedic Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.) Males and females aged between 18 and 50 years, complete as of the screening date.
2.) Participants with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
3.) Participants with BMI Less than or equal to 29.9 kg/m2.
4.) Participants with random blood sugar Less than or equal to 140 mg/dL.
5.) Upper respiratory tract infection symptoms present for at least 24 hours but not more than 72 hours prior to screening visit.
6.) Those having a score of more than or equal to 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough or head congestion on the Wisconsin Upper Respiratory Symptom Survey-21.
7.) Participants not requiring hospitalization.
8.) Participants with +ve/ -ve RT-PCR report.
9.) SPO2 level More than or equal 90%
10.) Systolic blood pressure Less than 130 mm Hg and/or diastolic blood pressure Less Than 90.
11.) Those who demonstrate an understanding of the study details and have a willingness to participate, as evidenced by voluntary written informed consent.
12.) Must be literate and have the ability to complete the study-based questionnaires and requirements
1.) High grade fever defined as body temperature More than or equal to 40°C.
2.) With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
3.) Chest X-ray showing signs of pneumonia.
4.) Participants with history of chronic obstructive pulmonary disease, pulmonary fibrosis or asthma
5.) Participants with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
6.) Participants with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
7.) Participants with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies.
8.) Participants with history of immunocompromised state immune system with/ without organ transplant.
9.) Participants with known or suspected hypersensitivity or intolerance to herbal products.
10.) Alanine transaminase (ALT) or aspartate transaminase (AST) More than or equal to 2.0 times the upper limit of normal.
11.) Participants diagnosed with Sickle cell disease, Thalassemia, Type I/ II diabetes mellitus, cystic fibrosis.
Diagnosed cases of hypertension.
12.) Those not willing to abstain from home based cold remedies that include but are not limited to steam inhalation, decoctions, vapour rub, ginger tea, honey tea, decoctions, or any form of dietary supplements during the entirety of study participation period.
13.) Those who have been vaccinated for influenza, swine flu or COVID three months prior to screening visit.
14.) Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines or other medications that are expected to alleviate cold symptoms within one week of the start of the study.
15.) Those who have participated in other clinical trials within 30 days, prior to the screening visit or plan to participate in other clinical trials during the trial period.
16.) Participants with substance abuse as per last two year history that includes the use of but is not limited to drugs such as cocaine, amphetamine, marijuana etc.
17.) Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
18.) Participants with heavy alcohol consumption.
19.) Those who have clinically significant disorder/s of cardiovascular, endocrine, lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervous system, musculoskeletal and digestive systems.
20.) Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity Outcome <br/ ><br>Change in total symptom severity scores from 0 to 7 (where 0 means not sick to 7 means severe) as assessed by Wisconsin Upper Respiratory Symptom Survey-21 on day 7 from baseline and in comparison to placeboTimepoint: Day 0, 1, 2, 3, 4, 5, 6, and 7
- Secondary Outcome Measures
Name Time Method Change in symptom resolutionTimepoint: Day 0 to day 7 (for all COVID positive participants) and Day 8 to day 15 (For COVID participants who didnt turn negative on day 8)];Minimal Important DifferenceTimepoint: Day0, 5 and 7;Percentage of participants with resolved common cold like complaints at the end of day 7 in comparison to placeboTimepoint: Day 7;Time to resolution of common cold like symptoms as assessed by participantTimepoint: Day 0, 1, 2, 3, 4, 5, 6, and 7;Visual Analogue Scale based severity outcomeTimepoint: Day 0, 1, 2, 3, 4, 5, 6, and 7