Evaluation of Clinical Efficacy of AOIM – Z Tablets for Prevention of COVID – 19 Pandemic in High Risk Healthy Police Personnel – Single Arm, Open Labelled, Prospective Exploratory Interventional Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Prevention of Incidence of COVID – 19 infection in study participants
研究概览
简要总结
This study is for assessing the clinical efficacy of AOIM – Z Tabletsfor prevention of COVID – 19 pandemics in high risk healthy police personnel. The study will have total 275 healthy police personnel who have high risk of developing COVID-19 due to their job profile.
The consenting individuals will be screened as per inclusion and exclusion criteria of this study. The selected participants will take Tab. AOIM-Z ,1 tablet every morning and evening with water or lukewarm water for 90 days. The study drug i.e. Tab. AOIM- Z is an Ayurvedic medicine, marketed since many years and has been proven as immunomodulator by animal studies. The follow up will be taken at day 45±5 and day 90± days online. A questionnaire has been prepared specifically for this study. The participants will receive this questionnaire through email and WhatsApp. Assessment of health for symptoms of COVID 19, assessment of perception of quality of life, and overall health will be covered through this questionnaire. The time required to fill the questionnaire may vary from ten to fifteen minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy, Male or Female participants between the age group of 21 to years to 55 years (both inclusive).
- •Healthy police personnel will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring and treatment.
- •2.Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements.
排除标准
- •1.Pregnant and Lactating females 2.Participants who have been quarantined or confirmed of having COVID-19 and have been isolated for its treatment.
- •Participants having recently suffered and recovered of COVID-19 will also be excluded from the study 3.Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 4.Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
- •5.Participants taking steroid treatment and or any kind of immunosuppressive therapy 6.Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.
- •7.Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol.
结局指标
主要结局
Prevention of Incidence of COVID – 19 infection in study participants
时间窗: 6 weeks(45 days) and 12 weeks (90 days)
次要结局
- a)Comparative assessment of severity of COVID-19 (if it occurs) in study participants(b)Comparative assessment of incidence and severity of allergic conditions (non-infective) leading to sneezing, running nose, sore throat etc.)