COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58414

Ankit Kumar

seeamol83@gmail.com

2021-07-19

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1] Healthy volunteers with normal liver and kidney function, normal hemogram and ECG, urine routine, chest X-ray examination, negative urine drug screen, negative HIV, HCV, HbsAg as assessed by baseline investigations <br/ >2] Age between 18 to 55 years <br/ >3] Either gender <br/ >4] Ready to give consent and willing to undergo experiment and comply with protocol <br/ >

1. Age < 18 and > 55 years. <br/ >2. Patients with moderate or severe disease. <br/ >3. Pregnant and lactating population. <br/ >4. Patients not giving consent for the study. <br/ >

2

Amol N Patil

18

55

India

Mild disease at enrollment

1: Mild disease at enrollment

110

1. To assess the safety and determine maximum tolerated dose of Essential oil blend nebulization by evaluating the toxicities including: type; frequency; severity; attribution and duration. <br/ >2. To assess the efficacy of EOs nebulisation in preventing respiratory symptoms development in asymptomatic and mild disease COVID-19 positive patients <br/ >3. To assess the efficacy of EOs nebulisation in respiratory symptom relief in mild disease COVID-19 positive patients. <br/ >Timepoint: Baseline; Day 3; 5; 7; 10 and !4

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

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 480, "treatment_name": "Essential oils", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]