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COMPLETED
NCT07835620
PHASE4

A Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.

Sponsor: Dasan Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

Placebo Matching Umckamin

One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.

DRUG

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