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A randomized, open, parallel controlled, multi-center clinical study to evaluate the efficacy and safety of Lianhuaqingke Tablets in the treatment of children with acute bronchitis (phlegm-heat obstructing the lung syndrome)

A randomized, open, parallel controlled, multi-center clinical study to evaluate the efficacy and safety of Lianhuaqingke Tablets in the treatment of children with acute bronchitis (phlegm-heat obstructing the lung syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052112
Enrollment
Unknown
Registered
2021-10-17
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

acute bronchitis

Interventions

Experimental group:Lianhua Qingke Tablets+Basic treatment
Control group:Basic treatment

Sponsors

Hebei Province Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for acute bronchitis in children; 2. Comply with the syndrome differentiation standard of phlegm-heat obstructing lung syndrome in traditional Chinese medicine; 3. Score of cough >= 2 points; 4. Course of illness <=72 hours; 5. Aged 3 to 14 years; 6. The informed consent process complies with the regulations, and the legal agent or the child under trial shall sign the informed consent form together.

Exclusion criteria

Exclusion criteria: 1. Subject with acute infectious diseases such as measles, whooping cough and influenza should be excluded; 2. Subject with acute upper respiratory tract infection, bronchial asthma, bronchiolitis, bronchial pneumonia, acute exacerbation of chronic bronchitis and other respiratory diseases should be excluded; 3. Serum creatinine (Cr), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) exceed the upper limit of normal; 4. Children with malnutrition, immunodeficiency, and tuberculosis should be excluded; 5. Combined with serious primary diseases such as severe heart, liver, kidney, digestive and hematopoietic system; 6. Those who are allergic to the investigational drug or its components; 7. Participated in other drug clinical trials within the past month; 8. The investigator thinks it is not suitable to be enrolled in the trial.

Design outcomes

Primary

MeasureTime frame
Median time to disease recovery;

Secondary

MeasureTime frame
Cough disappearance time;Onset time of cough relieving;Traditional Chinese Medicine Syndrome Points;

Countries

China

Contacts

Public ContactGeng Shaoyi

Hebei Province Hospital of Traditional Chinese Medicine

zhoupp@126.com+86 18832118662

Outcome results

None listed

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