A clinical trial of a new product to understand the effectiveness and safety to manage the symptoms of covid positive adult patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/12/029902
- Lead Sponsor
- Omshree Sidha Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult patients between 18 years and 65 years old, both men or women.
2. Subject with confirmed mild to moderate to severe COVID-19 in less than 5 days, preferably who has a history of Asthma, Pneumonia, Heart disease or Diabetic and who meets any of the following criteria:
a. Respiratory distress, RR � 30 times/min
b. In resting state, finger oxygen saturation (SpO2) �93%
c. X-ray of chest showing evidence of pulmonary infiltrates.
3. The informed consent signed.
4. Subjects willing to comply with the study Protocol.
1. Creatinine level is less than 1.10.
2. History of severe liver or kidney diseases.
3. History of any malignancies.
4. Subjects who are hypersensitive to herbal medications.
5. Subjects who are participating in any other trial within 30 days prior to consent.
6. Pregnant or lactating women.
7. Any other circumstances that the investigator considers inappropriate for the participation in this study.
8. Subjects who are unwilling to follow the study plan.
9. Any condition which subject may have which can cause increase risk of bleeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Time taken to reach Covid-19 negative <br/ ><br>2. Improvement of body temperature from baseline. <br/ ><br>3. Time taken to reach the change in RR from baseline to Day 4 and Day 8. <br/ ><br>4. Change in SpO2 from baseline to Day 4 and Day 8. <br/ ><br>5. Change in chest X-ray from baseline to Day 4 and Day 8. <br/ ><br>6. Time taken for nasal/chest symptoms to become normal from baseline. <br/ ><br>7. Duration of oxygen therapy <br/ ><br>8. Duration of hospitalization <br/ ><br>Timepoint: Screening, Day 0, 4 8 and 21 (in severe cases) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Physical Examination <br/ ><br>2.Any reports of adverse or serious adverse events during the treatment period. <br/ ><br>3.Significant change in laboratory parameters Any abnormal vital signs.Timepoint: Screening, Day 0, 4 8 and 21 (in severe cases)