NCT06411925 The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients
| NCT ID | NCT06411925 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | SamA Pharmaceutical Co., Ltd |
| Condition | Acute Bronchitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 296 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 296 participants in total. It began in 2023-11-10 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
Eligibility Criteria
Inclusion Criteria: 1. Children aged ≥6 months to \<12 years old 2. Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4 3. Wheezing score ≥2 4. Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit 5. Subject with negative results in HbsAg or HCV Ab test within 6 months from screening visit Exclusion Criteria: 1. Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis) 2. Subjects under treatment with corticosteroids, antibiotics medications 3. Subjects with severe hepatic and renal impairment 4. Subjects with a history of drug abuse 5. Subject with positive results in HIV Ab test
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06411925 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 11 Years, studying Acute Bronchitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06411925 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06411925 currently recruiting?
Yes, NCT06411925 is actively recruiting participants. Contact the research team at ilove902@hanmail.net for enrollment information.
Where is the NCT06411925 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06411925 clinical trial?
NCT06411925 is sponsored by SamA Pharmaceutical Co., Ltd. The trial plans to enroll 296 participants.