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Completed

NCT Number: NCT02250027

A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)

The purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis.

- BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum

Completed

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyung Hee University Hospital

Seoul, 130-872, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both gender, 19 years ≤ age ≤ 80 years
  • Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* ≥ 5point at Visit1 and Visit2
  • Written consent voluntarily to participate in this clinical trial

Exclusion criteria

  • Patients who were increased the bleeding tendency
  • Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range
  • Patients who investigators determines to severe respiratory disease that would interfere with study assessment
  • Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
  • Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
  • Patients who were treated with oral β2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect within 1 weeks prior to study participation
  • Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing
  • Patients with drug or alcohol abuse
  • Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery)
  • The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
  • Pregnant or breast-feeding
  • Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
  • Patients who investigators determines not appropriate to take part in this clinical study

Treatment and study plan

HL301 300mg capsule

Drug

2 capsules at once, 3 times a day, for 7 days

Other names: experimental A (0.6g/day) : HL301 300mg 2 capsule, experimental B (1.2g/day) : HL301 300mg 4 capsule, experimental C (1.8g/day) : HL301 300mg 6 capsule

Placebo

Drug

2 capsules at once, 3 times a day, for 7 days

Other names: Microcrystalline Cellulose

Primary outcomes

  1. Bronchitis Severity Score

    Time frame: baseline(day 0) and day 7

    Bronchitis Severity Score

Secondary outcomes

  1. Breathlessness, Cough, and Sputum Scale

    Time frame: baseline(day 0) and day 7

    Breathlessness, Cough, and Sputum Scale

  2. evaluation of symptoms of cough and sputum

    Time frame: baseline(day 0) and day 7

  3. Total usage of acetaminophen

    Time frame: baseline(day 0) and day 7

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Acronym: HL301

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2014
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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