An Open Label, Prospective, Randomized, Parallel, Multi-center, Multi-Arm, Comparative Study to Assess the Efficacy and Safety of Goviro Soft Gel Capsule as an adjuvant with Imunocin tablet and SOC in patients with Upper Respiratory Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).
研究概览
简要总结
Sixty patients with upper respiratory tract infection will be included in this study. Patients will be enrolled into the study based on Inclusion & Exclusion Criteria, patient history, and safety measures. The duration of each patient’s participation in the study will be of approximately 14 days. There will be total 05 visits (02 site visits and 03 virtual visits) during the study.
Patients will be instructed to take IPs, with ambient temperature water for total 07 consecutive days at home. SOC treatment will be given as per the treating investigator. Instructions will be given for the same.
Treatment Arm 1: Control group on SOC
Treatment Arm 2: Goviro soft gel capsule [one capsule twice a day after meals (lunch & dinner) ] along with SOC
Treatment Arm 3: Goviro soft gel capsule [one capsule twice a day after meals (lunch & dinner)] + Imunocin tablet (one tablet twice a day) along with SOC
Patients will be given WURSS-21 questionnaire to record their daily symptoms at home. They will be also given cold symptom score scale.
Patients will be followed up telephonically on Day 14 (Visit 5, virtual visit) for capturing details of adverse events and concomitant medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/female of ≥18 and ≤65 years of age 2.Patient who can and willing to provide written Informed Consent 3.Patient with at least 2 symptoms of URTI (Sneezing, Runny nose, nose block, sore throat, fever, fatigue) since last 48 hours 4.Patient who can take medicines orally 5.Female of childbearing potential must have a negative urine pregnancy test and be non-lactating at screening visit 6.Patient/ patient’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
排除标准
- •1.Patient Ë‚ 18 or ˃ 65 years of age 2.Pregnant and/or nursing woman 3.Patient with clinical evidence of a lower respiratory tract infection, as determined by the Investigator at the time of screening 4.Patient with anticipated need for hospitalization or emergency room care within 24 hours of screening 5.Patient with any other clinically significant illness 6.Patient with cases/ instances of severe vomiting which would affect oral administration of medicine 7.Patient taking any medication or having an indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and in the judgment of the study personnel, would make the subject inappropriate for inclusion 8.Patient who has participated in another trial with an investigational drug within 3 months prior to this trial.
- •9.Patient with history of malignancy, Cardiovascular Disease (CVD), Stroke, etc.
- •10.Patient with moderate to severe COVID 19 symptoms 11.Patient with any other condition, which as per the investigator would jeopardize the outcome of the trial 12.Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
结局指标
主要结局
Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).
时间窗: Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7). | Change in Cold symptom scale score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).
Change in Cold symptom scale score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).
时间窗: Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7). | Change in Cold symptom scale score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).
次要结局
- Reduction in number of doses of Antibiotics from Baseline to End of treatment.(Change in Complete Blood Count (CBC), Erythrocyte sedimentation rate (ESR), C- Reactive Protein (CRP) from Screening Visit/ Enrolment Visit/ Baseline Visit to End of treatment)