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The Safety and Efficacy of Yu Ping Feng Granule on Children with Recurrent Respiratory Tract Infections: A Multicenter, Randomized, Double-Blind, Three-arm Trial

The Safety and Efficacy of Yu Ping Feng Granule on Children with Recurrent Respiratory Tract Infections: A Multicenter, Randomized, Double-Blind, Three-arm Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006847
Enrollment
Unknown
Registered
2015-05-18
Start date
2014-09-17
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

Recurrent Respiratory Tract Infections in Children

Interventions

Experimental Group:Yu Ping Feng Granule
Active Control Group:Pidotimod Oral Solution
Placebo Group:Placebo

Sponsors

Beijing Children Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Subjects are diagnosed as pediatric recurrent respiratory tract infections; 2. Subjects are not in acute infection or recovered from acute infection no less than 1 week; 3. The symptoms of subjects are in accordance to the traditional Chinese medicine syndrome category; 4. Age between 2 to 6; 5. Informed consent forms must be signed by parents or legal guardians of the subjects.

Exclusion criteria

Exclusion criteria: 1. Patients with respiratory infection caused by primary immunodeficiency disease, congenital pulmonary airway malformation, gastroesophageal reflux disease (GERD), and pulmonary dysplasia; 2. Used immunosuppressants or immunoenhancive drug within 1 month, or use other treatments for RRTI; 3. Patients with severe malnutrition, rickets, anemia, asthma, and/or other vital organ disease, including those ALT level exceed 1.5 times than normal upper limit, or Cr level exceed normal upper limit; 4. Patients who are allergic to the experimental drug or allergic to more than one food or drugs; 5. Subjects who Deemed to be not appropriate to attend the trial or having problem completing the trial; 6. Subjects who attended other clinical trials within 3 monthes.

Design outcomes

Secondary

MeasureTime frame
reduce the ratio of recurrent infections;Effects on TCM Symptoms;Effects on Single Symptom;Complete Blood Count;Blood Chemistry Tests;

Primary

MeasureTime frame
RRTI Cure rate;

Countries

China

Contacts

Public ContactShen Kunling

Beijing Children Hospital, Capital Medical University

kunlingshen1717@163.com+86 010-59616629

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026