Efficacy and safety of Thai recipes; Ha-rak, Juntaleela and Fatalaijone compare to Favipiravir in asymptomatic or mild COVID-19 patients
- Conditions
- confirmed RT-PCR for SAR-CoV-2 patients with asymptomatic or mild symptoms: Asymptomatic covid-19 patients, mild-symptom covid-19 patients, Ben-cha-lo-ka-wi-chian (Ha-rak), Juntaleela, Fatalaijone, Favipiravir, viral clearance
- Registration Number
- TCTR20211006004
- Lead Sponsor
- Giving Mind Nirvana Soul Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 400
1.20 (minimum) - 60 years of age
2.Diagnosis of COVID-19 infection confirmed by RT-PCR test for SAR-CoV-2
3.Asymptomatic or mild COVID-19 symptoms: fever, cough, malaise or headache
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 6 days
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 Thai recipes
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 ,clinical improvement Every day from Day0 to Day7 or until discharge vital sign, symptoms, oxygen saturation
- Secondary Outcome Measures
Name Time Method Viral clearance day 3, 5, 9, 13 or until result negative, Confirmed by RT-PCR Antigen test kit (ATK),ICU transfer rate any time point Number of patients who has been transferred to ICU,Mortality rate any time point Number of death,supplemental oxygen therapy requirement any time point number of patient who need oxygen therapy,ventilators requirement any time point number of patient who need ventilators,Safety assessment Day0 and day 7 Liver function test (AST, ALT, AP, Bilirubin)CBC, creatinine