CTRI/2023/03/050708尚未招募不适用
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 Limited1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in mean Nasal symptoms score (NSS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 ≥ 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 participant’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.
结局指标
主要结局
Change in mean Nasal symptoms score (NSS)
时间窗: Day 1 to Day 14
次要结局
- Change in mean Nasal symptoms score (NSS)(Day 1 to Day 7)
- Investigators global clinical impression (CGI)(At Day 14)
研究者
研究点 (1)
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