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The efficacy and safety of Fuganlin Oral Liquid for acute upper respiratory tract infections children (common cold with syndrome of Qi-deficiency and Wind-heat): a randomized, double-blind, double-dummy, parallel, active-controlled, multi-center clinical trial

The efficacy and safety of Fuganlin Oral Liquid for acute upper respiratory tract infections children (common cold with syndrome of Qi-deficiency and Wind-heat): a randomized, double-blind, double-dummy, parallel, active-controlled, multi-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003322
Enrollment
Unknown
Registered
2013-06-14
Start date
2013-07-08
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

acute upper respiratory tract infections in children

Interventions

treatment group:Fuganlin Oral Liquid
control group:Xiao'er Jiebiao Oral Liquid

Sponsors

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

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children with acute upper respiratory tract infections; 2. Patients with TCM syndrome of Qi-deficiency and Wind-heat; 3. Aged 1 to 12 years; 4. with course of disease<=48 hours; 5. Guardian submitted informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia, etc; 2. History of hyperpyretic convulsion; 3. Severe malnutrition, rickets patients, complication of severe primary diseases such as heart, brain, liver, kidney and hematopoietic systems; 4. Those who can’t use their disease or comorbidity to explain the increase of serum creatinine(Cr), urea nitrogen (BUN), alanine aminotransferase(ALT), as well as positive ("+") urine protein and urinary erythrocyte; 5. Allergic patients who are allergic to two substances, or those who are allergic to the pharmaceutical preparation of test drug or controlled drug; 6. Patients judged by doctors are likely to be lost to follow-up.

Design outcomes

Primary

MeasureTime frame
duration of cold;

Secondary

MeasureTime frame
treatment effect;proportion of secondary lower respiratory tract infection;effect of TCM syndrom;effect of sigle symptom;

Countries

China

Contacts

Public ContactSiyuan Hu
husiyuan1963@sina.com+86 022 27432275

Outcome results

None listed

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