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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004437
Enrollment
Unknown
Registered
2020-11-26
Start date
2020-11-23
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute bronchitis

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 count10x10^9/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.

Design outcomes

Primary

MeasureTime frame
Cough resolution rate;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactBing Mao

West China Hospital, Sichuan University

maobing@medmail.com.cn+86 18980601724

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026