A Phase 4 interventional study of DSP2505(Canium) and Umckamin in Acute Bronchitis, sponsored by Dasan Pharmaceutical Co., Ltd.. Completed at 12 sites in South Korea. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Dasan Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment
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.
This phase 4, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group non-inferiority trial was conducted at 12 hospitals in the Republic of Korea. Eligible patients had acute bronchitis with onset within 48 hours before randomization and a Bronchitis Severity Score (BSS) of at least 5 at screening and baseline. Following a screening period of up to 2 days, participants were randomized 1:1 to DSP2505 or Umckamin for 7 days. Randomization was stratified by baseline BSS (\<8 or >=8). Matching placebos maintained blinding. Assessments were performed at baseline and the Day 7 end-of-treatment visit.
The primary endpoint was change in BSS total score from baseline to Day 7. The clinical study report describes an analysis of covariance with treatment as a fixed effect and baseline BSS as a covariate. Non-inferiority was assessed by comparing the upper bound of the two-sided 95% confidence interval for the adjusted difference (DSP2505 minus Umckamin) with a margin of 1.10 points. The per-protocol set was the primary efficacy analysis population, with a supporting full-analysis-set analysis. Safety was assessed in participants who received at least one dose.
This registration was prepared after study completion and analysis of the results.
156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.
This study's enrollment of 223 is above the median of 185 across 105 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →This is the only study on the registry with Dasan Pharmaceutical Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSP2505 (Canium) one tablet plus one matching placebo for Umckamin, orally three times daily for 7 days.
Drug: DSP2505(Canium) · Drug: Placebo Matching Umckamin
Umckamin one tablet plus one matching placebo for DSP2505, orally three times daily for 7 days.
Drug: Umckamin · Drug: Placebo Matching 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.
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.
One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.
One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.
Change From Baseline in Bronchitis Severity Score (BSS) Total Score at Day 7
BSS is the sum of five symptom scores: cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea. Each is rated from 0 (absent) to 4 (very severe), giving a total of 0 to 20. Higher scores indicate greater symptom severity. Change is Day 7 minus baseline; a negative change indicates improvement.
Time frame: Baseline and Day 7
Change From Baseline in BSS Cough Score at Day 7
The cough component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Time frame: Baseline and Day 7
Change From Baseline in BSS Sputum Score at Day 7
The sputum component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Time frame: Baseline and Day 7
Change From Baseline in BSS Rales/Rhonchi Score at Day 7
The rales/rhonchi component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Time frame: Baseline and Day 7
Change From Baseline in BSS Chest Pain During Coughing Score at Day 7
The chest pain during coughing component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Time frame: Baseline and Day 7
Change From Baseline in BSS Dyspnea Score at Day 7
The dyspnea component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Time frame: Baseline and Day 7
Percentage of Participants With BSS Total Score Below 3 at Day 7
Response defined as BSS total score \<3 at Day 7.
Time frame: Baseline and Day 7
Percentage of Participants With a BSS Total Score Reduction of at Least 7 Points
Response defined as a reduction in BSS total score of at least 7 points from baseline to Day 7.
Time frame: Baseline and Day 7
Percentage of Participants Meeting Both BSS Response Criteria
Response defined as both a BSS total score \<3 at Day 7 and a reduction of at least 7 points from baseline.
Time frame: Baseline and Day 7
Change From Baseline in Cough Assessment Test (COAT) Total Score at Day 7
COAT assesses cough frequency, interference with daily activities, sleep disturbance, fatigue, and airway hypersensitivity. Each of five items is scored from 0 to 4, giving a total of 0 to 20. Higher scores indicate greater cough-related impairment. Change is Day 7 minus baseline; a negative change indicates improvement.
Time frame: Baseline and Day 7
Investigator-rated Global Improvement at Day 7
The Integrative Medicine Outcome Scale (IMOS) rates change relative to baseline: 1=complete recovery, 2=major improvement, 3=slight to moderate improvement, 4=no change, and 5=deterioration. Lower scores indicate greater improvement. The distribution across the five categories is assessed.
Time frame: Day 7
Percentage of Participants With Investigator-rated Global Improvement at Day 7
The Integrative Medicine Outcome Scale (IMOS) rates change relative to baseline: 1=complete recovery, 2=major improvement, 3=slight to moderate improvement, 4=no change, and 5=deterioration. Lower scores indicate greater improvement. Improvement is defined as an IMOS rating of 1 or 2 by the investigator.
Time frame: Day 7
Percentage of Participants With Participant-rated Global Improvement at Day 7
The Integrative Medicine Outcome Scale (IMOS) rates change relative to baseline: 1=complete recovery, 2=major improvement, 3=slight to moderate improvement, 4=no change, and 5=deterioration. Lower scores indicate greater improvement. Improvement is defined as an IMOS rating of 1 or 2 by the participant.
Time frame: Day 7
Participant Satisfaction With Treatment at Day 7
The Integrative Medicine Patient Satisfaction Scale (IMPSS) is a five-category participant rating: 1=very satisfied, 2=satisfied, 3=neutral, 4=dissatisfied, and 5=very dissatisfied. Lower scores indicate greater satisfaction. The distribution across categories is assessed.
Time frame: Day 7
Number of Participants With Treatment-emergent Adverse Events
Participants experiencing adverse events arising after study medication administration, including serious adverse events, adverse drug reactions, and events leading to study discontinuation.
Time frame: From first dose through the Day 7 end-of-treatment assessment
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests
Clinically significant abnormalities in clinical laboratory tests are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Time frame: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Clinically significant abnormalities in vital signs are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Time frame: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Clinically significant abnormalities in physical examination are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Time frame: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram
Clinically significant abnormalities in electrocardiogram are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Time frame: Screening/before treatment and Day 7
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Individual participant data will not be shared to protect participant confidentiality. Study findings will be disseminated through scientific publications reporting aggregate results.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.