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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

A prospective, two-arm, 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 as a curative measures and as a management of Respiratory Allergies & Acute Sinusitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050708
Enrollment
30
Registered
2023-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J019- Acute sinusitis, unspecified

Interventions

None listed

Sponsors

Khoday Trading Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change in mean Nasal symptoms score (NSS)Timepoint: Day 1 to Day 14—

Secondary

MeasureTime frame
Change in mean Nasal symptoms score (NSS)Timepoint: Day 1 to Day 7;Investigators global clinical impression (CGI)Timepoint: At Day 14—

Countries

India

Contacts

Public ContactDr K G Padmanabhan

Khoday Trading Private Limited

pady72@rediffmail.com08040934216

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026