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Tong Kexin ® Xiao'er Feike Granule in the Treatment of Children with Respiratory Tract Infection and Gastrointestinal Symptoms Cohort Study Protocol

A cohort study of Tong Kexin ® pediatric pulmonary cough granules in the treatment of children with respiratory tract infection complicated with gastrointestinal symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2024000415
Enrollment
Unknown
Registered
2024-09-11
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Respiratory tract infections with gastrointestinal symptoms in children

Interventions

Pediatric pulmonary cough granules combined with conventional treatment of Western medicine:Intervention measures in the exposure group according to the actual clinical situation: the doctor recommend
Western medicine conventional treatment group:According to the actual clinical situation, the doctor can be combined with the actual situation of the patients diagnosis and treatment prescription, the

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Clinically confirmed acute respiratory tract infection (acute upper respiratory tract infection, acute branch tracheitis or pneumonia) with cough and/or sputum production; 2. Associated gastrointestinal symptoms, including loss of appetite, diarrhea, bloating, abdominal pain or hyperthermia stool dryness, knots, etc.; 3. TCM syndrome differentiation for children with lung and spleen qi deficiency syndrome; 4. Age 6 months~14 years old; 5. The informed consent process should be compliant.

Exclusion criteria

Exclusion criteria: 1. Children with body temperature = 37.3°C; 2. Children with acute pharyngitis and acute tonsillitis; 3. Upper airway cough syndrome, gastroesophageal reflux cough, psychogenic cough, over other coughs such as allergic cough, drug-induced cough, and otogenic cough; 4. Children with organic diseases of the gastrointestinal tract; 5. Children with broad bean disease; 6. Children with allergies to the study drug.

Design outcomes

Primary

MeasureTime frame
Rate of remission of respiratory tract infections and gastrointestinal symptoms in children;

Secondary

MeasureTime frame
Change value and effective rate of TCM syndromesChange value and effective rate of TCM syndromes;Change in total score of respiratory tract infection complicated with gastrointestinal symptoms in children;Single symptom avoidance/response;

Countries

China

Contacts

Public ContactGong Sitang

Guangzhou Women and Children's Medical Center

sitangg@126.com+86 189 0226 8811

Outcome results

None listed

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