Clinical Research for Luohuazizhu Granule on Children with Acute Tonsillitis (Syndrome of Wind-Heat Invading Lung): a Randomized Double-Blind Placebo-Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003485

Enrollment

Unknown

Registered

2020-07-13

Start date

2020-09-01

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

Children with Acute Tonsillitis (Syndrome of Wind-Heat Invading Lung)

Interventions

experimental group:Luohuazizhu Granule

control group:Luohuazizhu Granule Placebo

Eligibility

Sex/Gender

All

Age

3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria of western medicine of acute tonsillitis in children; 2. Diagnostic criteria of Traditional Chinese Medicine of acute tonsillitis in children (syndrome of wind-heat invading lung); 3. Age between 3-14 years old, male or female; 4. The course of the disease is within 48 hours without any medication; 5. Family members voluntarily sign the informed consent form; 6. 10 * 10^9/L 70%; 8. CRP > 5mg/L (Immunoturbidimetric assay); 9. PCT > 0.5ug/L.

Exclusion criteria

Exclusion criteria: 1. Body temperature is over 40 degrees C; 2. Combined with acute bronchitis, acute laryngitis and other respiratory diseases; 3. Combined with heart, liver, kidney, lung and other primary diseases (Such as liver function or renal function >= 1.5 times the normal value); 4. Complicated with severe complications such as tonsil abscess, otitis media and myocarditis; 5. Diagnose with diphtheria, pharyngitis, scarlet fever, infectious mononucleosis, measles, influenza, granulocytosis, leukemia, EPstein-Barr virus infection, etc. 6. Children who meet any of the following criteria: (1) Tonsillar attack no less than 7 times in the previous year; (2) Tonsillar attack no less than 5 times in the previous 2 year; (3) Tonsillar attack no less than 3 times in the previous 2 year. 7. Those who are known or suspected to be allergic to the test drug and its components; 8. Those with neurological or mental disorders who can not or are unwilling to cooperate; 9. Those who participated in other clinical trials 3 months ago.

Design outcomes

Primary

Measure	Time frame
clinical efficacy;	—

Secondary

Measure	Time frame
Temperature monitoring index;cure rate;WBC;PCT;CRP;Percentage of central granulocytes;	—

Countries

China

Contacts

Public ContactMa Rong

The First Teaching Hospital of Tianjin University of TCM

mr1974@163.com+86 13803093399

Outcome results

None listed

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