Acute Upper respiratory tract infection in children (wind heat cold syndrome)
Conditions
Interventions
Test group:Experimental group: 4-6 year old children with Lianhua Qinggan granules, 2 bags/time, 3 times a day
7-12 year old children's Lianhua Qinggan Granules, 3 bags/time, 3 times a day
control group:Control group: 4-6 year old children's Lianhua Qinggan Granule Simulator, 2 bags/time, 3 times a day
7-12 year old children's Lianhua Qinggan Granule Simulator, 3 bags/time, 3 times a day
Sponsors
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) It conforms to the diagnostic criteria of western medicine for children with acute Upper respiratory tract infection and the differentiation criteria of traditional Chinese medicine for wind heat cold syndrome; (2) Age 4-12 years old (<13 years old); (3) The course of illness before enrollment is = 48 hours; (4) The informed consent process should comply with the regulations, and the Legal guardian or the child (= 8 years old) should sign the informed consent form together.
Exclusion criteria
Exclusion criteria: (1) Other respiratory tract infections or infectious diseases such as pharyngeal conjunctival fever, Herpangina, suppurative Tonsillitis; (2) The white blood cell count and the absolute value of neutrophils both exceed 1.2 times the ULN, and the researchers consider them as bacterial infections; (3) Individuals with a history of epilepsy or febrile seizures; (4) Complicated with severe malnutrition, Rickets, or other serious systemic diseases such as cardiovascular, brain, liver, kidney and hematopoietic system, any respiratory anatomy abnormality, or immune deficiency, or mental illness; (5) Those who have taken Chinese and western medicines for acute Upper respiratory tract infection within 2 days before enrollment, which seriously affect the effectiveness evaluation; (6) Individuals who are allergic to known ingredients of the experimental drug; (7) Glucose-6-phosphate dehydrogenase deficiency (broad bean disease); (8) Researchers believe that individuals should not be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate of the disease (on the 6th day after the first medication); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure rate of the disease (2, 3, 4, and 5 days after the first medication);Clinical recovery time of the disease (h);The Canadian Acute Respiratory Disease and Influenza Inventory (CARIFs) and its total score changes in symptom dimensions (4th and 6th days after initial medication);Complete fever relief time (h);Changes in Traditional Chinese Medicine Syndrome Score (on the 4th and 6th days after the first medication);Effective rate of traditional Chinese medicine syndrome (on the 4th and 6th days after the first medication);Single symptom disappearance rate (4th and 6th days after the first medication);The significant improvement rate of the clinical efficacy evaluation scale (CGI-I) score by the child's guardian and doctor; (Daily evaluation by the child's guardian, and evaluation by the research doctor on the 4th and 6th days after the first medication);The incidence of complications;Emergency medication usage ratio and dosage; | — |
Countries
China
Contacts
Public ContactLi Xinmin
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed