Acute uncomplicated upper respiratory tract infection Upper respiratory infection Plant Extracts Phytotherapy Acanthaceae
Conditions
Interventions
400 mg/capsule, containing Andrographolide 20mg,Microcrystalline Cellulose 400mg
Active Comparator Drug,Placebo Comparator Drug
NANTH Soregone Capsule,Placebo Capsule
Sponsors
Thailand Center of Excellence for Life Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-60 years 2. Diagnosed as acute upper respiratory tract infections 3. Onset of cold symptoms within 48 hours before screening 4. Fever greater than or equal to 37.8 Degree Celsius and had at least two other clear symptoms of the common cold, such as, cough, runny nose, nasal congestion, headache, earache, sore throat, fatigue, hoarseness, sleep disturbance, and sneezing. 5. Patients who understand the aim and contents of the trial and can perform symptom assessment questionnaire 6. Patients who are able to visit on days 5
Exclusion criteria
Exclusion criteria: 1. Patients with severe symptoms or unstable vital signs, including a body temperature greater than 40 Degree Celsius and/or a heart rate greater than 100 beats/minute, and/or a respiratory rate greater than 24 breaths/minute. 2. Patients who are diagnosed/suspected with bacterial infection or prescribed antibiotics 3. Patients who had positive rapid test for influenza viruses or COVID-19 on screening 4. Patients who had positive test for Dengue NS1Ag on screening 5. Warning symptoms of upper airway obstruction or pneumonia 6. Received antibiotics or other herbs intake systemically within 48 hours 7. Patient with a history of allergy to A. Paniculata or its extract 8. Allergic to paracetamol 9. History or current alcohol or substance dependence 10. Pregnancy or breastfeeding 11. On chemotherapy 12. Organ transplantation within the past 1 year 13. Had Alanine transaminase (ALT) and aspartate transaminase (AST) levels more than 2.5 times the upper limit 14. Had Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 15. Patients with medical conditions or any medication that may interfere with investigational product or outcome assessment 16. Currently on warfarin or other medications metabolized primarily via CYP3A4, CYP 1A2, CYP 2C9 or CYP2D6 17. Patients currently receiving antiretroviral therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in overall and individual acute upper respiratory tract infection symptoms Day 5 Visual Analog Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in overall and individual acute upper respiratory tract infection symptoms Day 1, 2, 3, 4 Visual Analog Scale,Time to symptom recovery Day 1, 2, 3, 4, 5 Visual Analog Scale,Time to sustain the recovery Day 1, 2, 3, 4, 5 Visual Analog Scale,Median time (in days) to URTI symptom resolution Day 1-5 Subject diary card,Improvement of VAS scores among symptom-onset time groups Day 1-5 Visual Analog Scale,Percentage of patients recovered at different time points Day 1-5 Subject diary card,Amount of paracetamol and chlopheniramine used Day5 Count of dispensed vs returned medication | — |
Countries
Thailand
Contacts
Public ContactChairat Permpikul
Department of Medicine, Faculty of Medicine Siriraj Hospital
Outcome results
None listed