Common cold Common cold
Conditions
Interventions
A. paniculata extract capsules at a dose of one capsule, three times per day (providing a total of 60 mg of andrographolide per day), for five consecutive days,Placebo at a dose of one capsule, three
Experimental Drug,Placebo Comparator Drug
A. paniculata extract capsules,Placebo
Sponsors
K Agro-innovate Institute
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and 60 years, both male and female 2. Diagnosed by a physician with the common cold and presenting at least two symptoms (runny nose, nasal congestion, sneezing, cough, sore throat, low-grade fever, or headache) within 48 hours before the screening period 3. Able to read and write in Thai 4. Provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Fever exceeding 38.5 C 2. Pregnancy or breastfeeding 3. Presence of significant underlying medical conditions 4. History or presence of immune-related disorders 5. Presence of significant respiratory conditions 6. History or presence of coagulation disorders 7. Current use of medications metabolized primarily via Cytochrome P450 (CYP 450) enzymes 3A4, 1A2, or 2C9 8. Current use of antiplatelet, anticoagulant, or NSAIDs 9. Current use of immunosuppressive agents 10. Known or suspected allergy or hypersensitivity to A. paniculata or any component of the investigational product 11. History of vaccination within one month or intends to receive vaccination during the study 12. History or current use of medications/products that may interfere with outcome assessments 13. History of or current heavy smoking, alcohol dependence, or use of other addictive substances 14. Current participation in other clinical research studies, or plans to undergo surgery during the study period 15. Significant laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cold symptoms (severity score), including runny nose, nasal congestion, sneezing, cough, headache, sore throat, fatigue, body aches, and sleep disturbances Day 1 to Day 5 Visual analog score, ranging from no symptom to worst possible severity | — |
Secondary
| Measure | Time frame |
|---|---|
| Cold symptoms (impact score) Day 1 to Day 5 Visual analog score,Inflammatory cytokines (IL-6, IL-8, and IFN-gamma levels) Day 0, Day 2, Day 5 bead-based immunoassays,Safety parameters Day 0, Day 5 Laboratory tests,Adverse effects (e.g., gastrointestinal adverse effects) Day 1 to Day 5 History taking and physical examination | — |
Countries
Thailand
Contacts
Public ContactNut Koonrungsesomboon
Chiang Mai University
Outcome results
None listed