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

Khoday Trading Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•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.

发起方

Khoday Trading Private Limited