A Clinical Study to Evaluate the Safety and Efficacy of NIOX-G Ayurvedic Nasal Spray against Upper Respiratory Tract Viral infections in Vaccinated/ Unvaccinated adult Patients
- Conditions
- Health Condition 1: J019- Acute sinusitis, unspecified
- Registration Number
- CTRI/2023/03/050708
- Lead Sponsor
- Khoday Trading Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all study procedures.
2. Male or Female subjects aged between 18 to 65 years (both inclusive).
3. Subjects with Upper Respiratory Tract Viral infections/ Respiratory Allergies (Allergic Rhinitis) / Acute Sinusitis.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at
screening visit.
1. Subjects with any history of underlying uncontrolled medical illness (such as diabetes, hypertension, liver disease or history of
alcoholism, HIV, chronic hepatitis B, hepatitis C Infection or any other serious medical illness).
2. Subjects who are receiving corticosteroids (in a dose equivalent to >= 20 mg prednisone per day), immunosuppressive radiation therapy, or cytotoxic agents.
3. Females who are breastfeeding, pregnant, or attempting to become pregnant.
4. Patients who had undergone nasal surgery within the previous 6 months
5. Patients with nasal polyps, significant deviation of the nasal septum or significant nasal tract structural malformation.
6. Patients with a history of chronic sinusitis, asthma or any other condition that can interfere with the aim of the study.
7. Subjects who have any other condition that, in the opinion of the Investigator, would interfere with a participantâ??s ability to adhere to the protocol (e.g., participants who are mentally or
neurologically disabled and who are considered not fit to their participation in the study), interfere with assessment of the
investigational product, or compromise the safety of the participant or the quality of the data.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean Nasal symptoms score (NSS)Timepoint: Day 1 to Day 14
- Secondary Outcome Measures
Name Time Method Change in mean Nasal symptoms score (NSS)Timepoint: Day 1 to Day 7;Investigators global clinical impression (CGI)Timepoint: At Day 14