A Double-Blind, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of Nasal Spray in Paediatric and Adolescent Subjects with Symptoms of Common Cold
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Mean change in Total Symptom Score (TSS) and Viral Load at different time points in treatment arm in comparison with Baseline and comparator
研究概览
简要总结
This is a double blind, randomized (1:1), comparatorcontrolled, parallel-group, multi-centre study to test the product safety andefficacy in relieving cold symptoms in Paediatric and Adolescent subjects withearly symptoms of common cold and meeting all inclusion and no exclusioncriteria. Study duration is for 21 days with intervention period of 14 days.After passing the eligibility criteria, written Informedconsents and Assents will be obtained and the subjects will be randomized intoone of the 2 treatment groups as per randomization schema. Homogenous andUniform distribution of subjects in both groups basis symptom severity(Mild andModerate), gender, mean age yrs will be attempted. Cold severity as per specific measures, Local irritation willbe assessed by Investigator and Subjects / parents/ Guardians under supervisionof study Investigator / personnel at specified frequency.Viral load assessmentthrough nasal swabs will be performed on Day 1 and Day 4. Subjects will begiven a detailed instruction on product use and recording in the subject dairy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with common cold symptoms.
- •2.Subjects with cold symptom severity within the specified score range.
- •3.Subject who agrees to give informed consent / assents and comply with the study procedures.
排除标准
- •Subjects with history/presence of clinically significant condition/disorder/allergy to herbal products (self-reported), or regularly consuming certain products as per invetigator judgement could interfere with the results of the study or the safety of the subject.
- •Subjects tested positive for SARS-CoV-2 by Rapid Antigen Test.
- •Subjects who test negative for viral load at baseline.
- •Subjects with co-existing bacterial/secondary infections.
- •Subjects having taken influenza vaccination within the last 3 months prior to screening visit.
- •6.Subjects having common cold or flu like symptoms for > 48 hours.
结局指标
主要结局
Mean change in Total Symptom Score (TSS) and Viral Load at different time points in treatment arm in comparison with Baseline and comparator
时间窗: Day 2/ 3/ 4/ 5/ 7
次要结局
- Mean change in efficacy parameters including Questionnaire based assessments at different time points up to 21 days(Upto Day 21)
- Percent of individuals with relapse post intervention(Upto Day 21)
- Overall product safety(Upto Day 21)