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CompletedNCT03309800Updated Oct 16, 2017

A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

A Phase 2 interventional study of HL301 and HL301(Placebo) in Acute Bronchitis, sponsored by Hanlim Pharm. Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-16.

Sponsored by Hanlim Pharm. Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2017, registered Sep 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study summary

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients.

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen

02

Conditions studied

  • Acute Bronchitis

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Keywords

  • Acute Bronchitis
03

In context

Bronchitis

156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.

This study's enrollment of 168 is close to the median of 185 across 105 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Hanlim Pharm. Co., Ltd. is the lead sponsor of 50 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Both gender, 19 years ≤ age ≤ 80 years
  2. (Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit)
  3. Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
  4. Those who can comply with the requirements of clinical trials
  5. Written consent voluntarily to participate in this clinical trial

Exclusion criteria

Exclusion Criteria:

  1. Patients with respiratory and systemic infections requiring systemic antibiotic therapy
  2. Patients with bleeding tendency
  3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
  4. Patients who were treated with oral systemic adrenocortical hormone or drug within 4 weeks prior to Visit 2
  5. Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
Terms in these criteria, in plain language(1)

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Experimental

    HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

    Drug: HL301

  • Placebo comparator
    Placebo comparator

    HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

    Drug: HL301(Placebo)

Interventions

  • DrugHL301

    HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

  • DrugHL301(Placebo)

    HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

06

What researchers measure

Primary outcomes

  1. Bronchitis Severity Total Score(BSS) Change

    Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

    Time frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

Secondary outcomes

  1. The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)

    Evaluation period: Visit 3 (7 day)

    Time frame: Visit 3 (7 day)

  2. The satisfaction of the subject (Questionnaire)

    Evaluation period: Visit 3 (7 day)

    Time frame: Visit 3 (7 day)

  3. Total usage of Acetaminophen

    Evaluation period: Visit 3 (7 day)

    Time frame: Visit 3 (7 day)

07

Study locations

1 site
  • Kyung Hee University Hospital
    Seoul, Dongdaemun-gu 130-872, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03309800
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Mar 29, 2017
Primary completion
Aug 17, 2017
Completion
Aug 28, 2017
Last update
Oct 16, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: R. glutinosa/P. suffruticosa/S. chinensis/A. cochinchinensis/P. armeniaca/S. baicalensis/S. sessilifolia Herbal Supplement HL301

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