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

Not yet recruiting

Conditions: Acute sinusitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH,

Brief Summary: This is a prospective,single blind, single centre, 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. The study consists of 2 Arms in which 1 arm will receive the standard therapy along with NIOX-G and another arm will receive standard therapy and placebo

Recruitment & Eligibility

Inclusion Criteria

Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all study procedures.
Male or Female subjects aged between 18 to 65 years (both inclusive).
Subjects with Upper Respiratory Tract Viral infections/ Respiratory Allergies (Allergic Rhinitis) / Acute Sinusitis.
Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study.

Exclusion Criteria

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).
Subjects who are receiving corticosteroids (in a dose equivalent to â‰¥ 20 mg prednisone per day), immunosuppressive radiation therapy, or cytotoxic agents.
Females who are breastfeeding, pregnant, or attempting to become pregnant.
Patients with nasal polyps, significant deviation of the nasal septum or significant nasal tract structural malformation.
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.

Primary Outcome Measures

Name	Time	Method
Change in mean Nasal symptoms score (NSS)	Day 1 to Day 14

Secondary Outcome Measures

Name	Time	Method
Change in mean Nasal symptoms score (NSS)	Day 1 to Day 7
Investigators global clinical impression (CGI)	At Day 14

Locations (1): Government Medical College & Government General Hospital
🇮🇳
Srikakulam, ANDHRA PRADESH, India
Government Medical College & Government General Hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
Dr K Sunil Naik
Principal investigator
8942279033
drsunilnaikggh@gmail.com