Efficacy and safety of Herbal Drink in mild to severe COVID-19 patients: pilot study

Phase 2

• Conditions: confirmed RT-PCR for SAR-CoV-2 patients with mild to severe symptoms; mild-symptom covid-19 patients, moderate-symptom covid-19 patients, severe-symptom covid-19 patients, Herbal Drink, Favipiravir, viral clearance

• Registration Number: TCTR20220204005
• Lead Sponsor: Giving Mind Nirvana Soul Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-04
• Study Completion: 2023-01-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 20 (minimum) years of age 2. Diagnosis of COVID-19 infection confirmed by RT-PCR test for SAR-CoV-2 3. mild to severe COVID-19 symptoms 4. No uncontrollable underlying disease 5. Onset of symptoms is within 5 days or positive RT-PCR for SAR-CoV-2 within 5 days 6. Signed informed consent provided by patient 7. Willing to stay at research site at least 10 days

Exclusion Criteria

1. COVID19 positive based on Antigen test but PCR negative 2. Severe or critical clinical conditions (Glasgow coma scale less than 14) 3. Severe COVID-19 4. Patient who is on mechanical ventilator 5. Abnormal chest x-ray 6. Dyspnea or respiratory rate above 30 per minute 7. Hypoxia or oxygen saturation less than 96 percent 8. Underlying diseases including Diabetes mellitus, uncontrollable hypertension 9. Abnormal liver function test: ALT/AST increased 5 times higher than the upper limit of normal or with Child Pugh C 10. Renal failure or Creatinine clearance (Cockcroft-Gault Equation) less than 30 ml/min or having hemodialysis/peritoneal dialysis 11. Known allergy or hypersensitivity to Herbal Drink 12. Pregnant (female of childbearing age with positive urine pregnancy test) or Lactating female

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Viral clearance at day 7 day 7 Nasopharyngeal swab and RT-PCR for SAR-CoV-2

Secondary Outcome Measures

Name	Time	Method
clinical improvement Every day from Day0 to Day7 or until discharge vital sign, symptoms, oxygen saturation