A Double-blind, Randomized, Parallel Groups, Placebo-Controlled, Comparative Study for assessing the Efficacy and Tolerability of AndroPan® in Individuals with upper respiratory infection with or without standard of care.
- Conditions
- Health Condition 1: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2023/08/056610
- Lead Sponsor
- K. PATEL PHYTO EXTRACTIONS PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
Subjects will be considered eligible for the study based on the following criteria
Participants will be included in the study if they fulfill each of the below mentioned criteria
1. Male or female aged between 18 to 50 years (inclusive), as of the screening date.
2. Individuals with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
3. Symptoms of upper respiratory tract infection present for at least 24 hours but not more than 72 hours priors screening visit.
4. Those having a score of = 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing, sore throat, scratchy throat, or head congestion on the WURSS-21.
5. Participants not requiring hospitalization.
6. Participants with negative COVID19 RT-PCR report
7. SPO2 level = 90%
8. Those who demonstrate an understanding of the study details and have a willingness to participate as evidenced by voluntary written informed consent.
9. Based upon investigators judgement, if any patient is on standard treatment of a condition like diabetes, cardiovascular or pain etc., which does not seem to affect the current study outcomes, then the patient can be included in the study.
Subjects will be excluded from the study based on the following criteria
Participants will be excluded from the study if they fulfill any of the following criteria
1. Participants not having COVID RT-PCR test report
2. Participants with history of COVID +ve, since more than 14 days from the date of screening.
3. High grade fever defined as body temperature = 40°C.
4. With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
5. Chest X-ray showing signs of pneumonia
6. Participants with history of Chronic obstructive pulmonary disease, pulmonary fibrosis or Asthma
7. Participants with rhinitis medicamentosa, chronic cough of Viral or allergic origin (other than bacterial and fungal) Participants with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
8. Participants with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
9. Participants with history of immunocompromised state immune system with/ without organ transplant
10. Participants with known or suspected hypersensitivity or intolerance to herbal products
11. Alanine transaminase (ALT) or aspartate transaminase (AST) = 2.5 times the upper limit of normal.
12. Participants diagnosed with Sickle cell disease, Thalassemia, Type I/ II diabetes mellitus, cystic fibrosis
13. Diagnosed cases of hypertension.
14. Those who have been vaccinated for influenza, swine flu or COVID, 3 months prior to screening visit.
15. 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.
16. Those who have severe mental illnesses, such as dementia, Parkinson’s disease, Alzheimer’s Disease, depression or anxiety disorders, or those who are currently taking psychoneurological drugs, such as antidepressants.
17. 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.
18. 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.
19. Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
20. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
21. Any condition that could, in the opinion of the investigator, preclude the participant’s ability to successfully and safely complete the study or that may confound study outcomes.
22. Based on investigator’s judgement, the patients requiring treatment which may affect outcome of the current study, like Anti-viral, Anti-microbial, Anti-inflammatory, Anti-allergic treatments etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Compare the Efficacy & tolerability of AndroPan with Placebo in Individuals with upper respiratory infection.Timepoint: Day 8
- Secondary Outcome Measures
Name Time Method To Compare the Safety of AndroPan with Placebo in Individuals with upper respiratory infection.Timepoint: Day 8