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A Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.
Sponsor: Dasan Pharmaceutical Co., Ltd.
Summary
This study compared two oral medicines containing Pelargonium sidoides extract in patients aged 12 to 75 years with acute bronchitis. Participants were randomly assigned to DSP2505 (Ckanium tablets) or Umckamin tablets for 7 days. The main question was whether DSP2505 was no worse than Umckamin by more than a defined margin in improving bronchitis symptoms. Symptoms, cough-related quality of life, overall improvement, satisfaction, and safety were assessed.
Official title: A Multi-center, Randomized, Double-blind, Active Control, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.
Key Details
Gender
All
Age Range
12 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
223
Start Date
2026-01-26
Completion Date
2026-09-09
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
DSP2505(Canium)
Canium film-coated tablet containing 20 mg of Pelargonium sidoides 11% ethanol dry extract (5.5-6.6:1). One tablet orally three times daily for 7 days.
Umckamin
Tablet containing 111.111 mg of Pelargonium sidoides 11% ethanol extract (1:8-10) and maltodextrin mixture (1:4.56), equivalent to 20 mg of dried extract. One tablet orally three times daily for 7 days.
Placebo Matching Umckamin
One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.
Placebo Matching DSP2505 (Canium)
One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.
Locations (12)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Dong-A University Hospital
Busan, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Wonkwang University Hospital
Iksan, South Korea
Incheon St. Mary's Hospital, The Catholic University of Korea
Incheon, South Korea
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Yeouido St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea