COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49842

Dr Deepa Subramanian

info@omshreeayur.com

2020-12-18

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Adult patients between 18 years and 65 years old, both men or women. <br/ >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: <br/ >a. Respiratory distress, RR â?¥ 30 times/min <br/ >b. In resting state, finger oxygen saturation (SpO2) â?¤93% <br/ >c. X-ray of chest showing evidence of pulmonary infiltrates. <br/ >3. The informed consent signed. <br/ >4. Subjects willing to comply with the study Protocol.

1. Creatinine level is less than 1.10. <br/ >2. History of severe liver or kidney diseases. <br/ >3. History of any malignancies. <br/ >4. Subjects who are hypersensitive to herbal medications. <br/ >5. Subjects who are participating in any other trial within 30 days prior to consent. <br/ >6. Pregnant or lactating women. <br/ >7. Any other circumstances that the investigator considers inappropriate for the participation in this study. <br/ >8. Subjects who are unwilling to follow the study plan. <br/ >9. Any condition which subject may have which can cause increase risk of bleeding.

2

Omshree Sidha Hospital

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

80

1.Time taken to reach Covid-19 negative <br/ >2. Improvement of body temperature from baseline. <br/ >3. Time taken to reach the change in RR from baseline to Day 4 and Day 8. <br/ >4. Change in SpO2 from baseline to Day 4 and Day 8. <br/ >5. Change in chest X-ray from baseline to Day 4 and Day 8. <br/ >6. Time taken for nasal/chest symptoms to become normal from baseline. <br/ >7. Duration of oxygen therapy <br/ >8. Duration of hospitalization <br/ >Timepoint: Screening; Day 0; 4 8 and 21 (in severe cases) <br/ >

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 928, "treatment_name": "Omshree savier/omshreeraj", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]