Efficacy and Safety of Tanreqing Oral Liquid in Treatment of Acute Bronchitis (Phlegm-Heat Obstructing Lungs Syndrome): a multicenter, randomized, double-blind, placebo-controlled trial

Phase 3

Recruiting

• Conditions: acute bronchitis

• Registration Number: ITMCTR2100004437
• Lead Sponsor: West China Hospital, Sichuan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of acute trachea-bronchitis;
2. Phlegm-heat obstructing lungs syndrome in traditional Chinese medicine 'Zheng';
3. Total cough symptom score >=4 points;
4. Expectoration in traditional Chinese medicine symptom score >=6 points;
5. Bronchitis severity score>=6 points;
6. Disease course within 72 hours;
7. Aged 18 to 65 years old;
8. Voluntarily provide written and informed consent.

Exclusion Criteria

1. Patients with respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer, tuberculosis, pneumonia, lung abscess and chest X-ray showing lung inflammation lesions;
2. Patient with severe underlying cardiac, cerebral, hematological, hepatic or renal disorders or other diseases significantly affecting the survival and prognosis, such as cancer;
3. Current smokers or recent ex-smokers quitting smoking less than 1 month ago;
4. Use of an angiotensin-converting-enzyme inhibitor in the last 1 month
5. Patients with body temperature>=38.5 degree C;
6. ALT or AST>1.5 ULN, urine protein>+, serum creatine abnormality, white blood cell count<3x10^9/L or >10x10^9/L, and or neutrophil granulocyte>80%, or those who need antibiotic therapy;
7. Those who have used other medicines after disease onset including antibiotics, expectorants, antitussives, systemic or inhaled corticosteroids, inhaled bronchodilators, Chinese medicines of relieving exterior syndrome with pungent-cool drugs, clearing away heat and detoxification and other related Chinese medicines;
8. Pregnant or lactating women and those who have pregnancy plans in the last 3 months;
9. Allergic constitution or known to be allergic to any ingredients in tested drug;
10. Mental patients or legal disability;
11. Patients who have participated or are currently participating in another clinical trial in the last one month;
12. Patients who are inappropriate for participation judged by researchers.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cough resolution rate;

Secondary Outcome Measures

Name	Time	Method
Change of bronchitis severity scores from baseline to post-treatment;Cough relief rate;Change of TCM syndrome score from baseline to post-treatment;Resolution rate of single TCM symptom;Combination medication use;Time to cough relief;Time to cough resolution;