Skip to content

Safety and Efficacy of Jinye Baidu granule in treatment of children with acute upper respiratory tract infection(heat in lung-wei pattern): a randomized, double-blind, very low dose parallel-controlled, multi-center trial

Safety and Efficacy of Jinye Baidu granule in treatment of children with acute upper respiratory tract infection(heat in lung-wei pattern): a randomized, double-blind, very low dose parallel-controlled, multi-center trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086889
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-07-18
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

acute upper respiratory tract infection(heat in lung-wei pattern)

Interventions

Treatment group:Jinye Baidu granule
Control group:Very low dose Jinye Baidu granule

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 13 Years

Inclusion criteria

Inclusion criteria: (1) Conforming to the western medical diagnostic criteria of acute upper respiratory tract infection in children and the TCM syndrome differentiation criteria of heat in lung-wei pattern; (2) The duration of disease before enrollment =48 hours;(3) Age 2-13 years old (< 14 years old); (4) The informed consent process was in accordance with the provisions, and the legal guardian or children (=8 years old) signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Combined with other respiratory infections or infectious diseases such as pharyngeal junctional membrane fever, herpangina, suppurative tonsillitis, acute bronchitis, acute pneumonia; (2) White blood cell count, absolute neutrophil count and C-reactive protein were higher than the upper limit of normal value, and the investigator considered bacterial infection.; (3) Patients with a history of epilepsy and febrile convulsions; (4) Complicated with severe malnutrition, rickets, or other serious systemic diseases of the cardiovascular, cerebral, hepatic, renal and hematopoietic systems, any anatomical abnormalities of the respiratory tract, or immunodeficiency, or mental illness.; (5)Taking Chinese or western medicine for acute upper respiratory tract infection within 2 days before enrollment, which seriously affected the effectiveness evaluation; (6) Allergic to known ingredients of investigational drugs; (7) Glucose-6-phosphate dehydrogenase deficiency (favism); (8) Patients who were considered unsuitable for enrollment by the investigators.

Design outcomes

Primary

MeasureTime frame
Clinical cure rate of diseases treated for 5 days;

Secondary

MeasureTime frame
Time to clinical recovery (days);Time to normalization of body temperature(hours);The change value of TCM syndromes score;Therapeutic effects on TCM syndromes;Normalization rate of single symptom;Incidence of complications;Percentage and dose of emergency medications (Paracetamol);

Countries

China

Contacts

Public ContactXinmin Li

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

tjtcmlxm@163.com+86 139 0209 5399

Outcome results

None listed

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