Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19 Disease in Healthcare Providers at Baqiyatallah Hospital in Tehran
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- PCR test
研究概览
简要总结
180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours.
At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Negative PCR testing through throat swabs
- •Signing Conscious Consent
排除标准
- •History of ocular complications and visual disturbances
- •Sensitivity to plant compounds in the product
研究组 & 干预措施
Control Group
Participants in this group use personal protective equipment in the face of patients with COVID-19
干预措施: Personal protective equipment (Device)
Intervention Group 1
In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.
干预措施: Hydroxychloroquine (Drug)
Intervention Group 1
In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.
干预措施: Personal protective equipment (Device)
Intervention Group 2
In this group, participants, while observing and using complete personal protective equipment, will apply a thin layer of Dentol gel to the vestibular area of the mouth daily, every 6 to 8 hours.
干预措施: Mucodentol (Drug)
Intervention Group 2
In this group, participants, while observing and using complete personal protective equipment, will apply a thin layer of Dentol gel to the vestibular area of the mouth daily, every 6 to 8 hours.
干预措施: Personal protective equipment (Device)
结局指标
主要结局
PCR test
时间窗: up to 1 month
Laboratory PCR testing can help diagnose the disease
次要结局
- Laboratory Treatment Response(up to 1 month)
- drug reactions Adverse(up to 1 month)
- Allergic drug(up to 1 month)
- Radiological Treatment Response(up to 1 month)
研究者
Mohammad Sadegh Bagheri Baghdasht
Principal Investigator
Baqiyatallah Medical Sciences University
