Randomized multicenter clinical evaluation of Xiaoer Dingchuan Granule in the intervention of respiratory syncytial virus pneumonia in children (phlegm-heat blocking lung syndrome)

Randomized multi-center clinical efficacy evaluation of Chinese medicine intervention on children respiratory syncytial virus pneumonia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061471

Enrollment

Unknown

Registered

2022-06-25

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Respiratory syncytial virus pneumonia in children

Interventions

Experimental group:Xiaoer Dingchuan Granule combined with glucocorticoid budesonide suspension

Control group:Glucocorticoid budesonide suspension

Eligibility

Sex/Gender

All

Age

1 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1. Children who meet the diagnosis of respiratory syncytial virus pneumonia; 2. Children who meet the TCM diagnosed pneumonia with dyspneic cough with syndrome of phlegm-heat blocking lung; 3. Aged from 1 to 5 years; 4. The course of RSV pneumonia is within 48 hours; 5. The legal guardian and the child who can understand and sign his/her name have understood and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Drugs taken within 24 hours before onset that may affect the efficacy evaluation of the test (such as antipyretic and analgesic drugs, antibacterial drugs, H1 receptor blockers, vasoconstrictor and Traditional Chinese medicines with the same efficacy as the test drugs, etc.); 2. Severe pneumonia in children (according to the criteria for classification of severity according to 2013 Guidelines for The Management of Community-acquired Pneumonia in Children); 3. Patients with onset of other respiratory diseases except pneumonia; 4. Allergic to the test drug; 5. Patients who have participated in or are participating in clinical trials of other drugs within the last 3 months; 6. According to the doctor's judgment, it is easy to cause the loss of follow-up.

Design outcomes

Primary

Measure	Time frame
The total response rate of the disease;Time window of therapeutic effect for pediatric syncytial virus pneumonia;	—

Secondary

Measure	Time frame
TCM syndrome effect;Single symptom curative effect;Combined with medication use;	—

Countries

China

Contacts

Public ContactWang Xuefeng

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

lnzywxf@163.com+86 13840208807

Outcome results

None listed

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