A multi - center, randomized, double-blind, parallel-controlled trial for the efficacy and safety of Lian-hua Qing-wen granules in the treatment of influenza in children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002856

Enrollment

Unknown

Registered

2019-12-20

Start date

2020-01-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

influenza

Interventions

Experimental group:Lian hua qing wen granules and its simulant: oral, 3-6 years old, 3g/ time

7 ~ 9 years old, 4.5g/ time

10 ~ 14 years old, 6g/ time. Three times a day.

The control group:Oseltamivir granules and their analogs: oral, weight =15kg, 2 bags/time

Weight > 15 ~ 23kg, 3 bags/time

Weight > 23 ~ 40kg, 4 bags/time

Weight: > 40kg, 5 bags/time, 2 times a day. If age =13, take 5 bags/time twice a day.

Eligibility

Sex/Gender

All

Age

3 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Patients meet the clinical diagnostic criteria for influenza; (2) Diagnosed as heat attack lung TCM syndrome; (3) Aged 3-14 years old; (4) The course of fever =38.5 degree C; (5) Tested positive for influenza infection using a rapid influenza diagnostic test (RIDT); (6) the informed consent process is in accordance with the provisions, and the legal representative or(and) the children (>=8 years old) co-sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe or critical cases of influenza, or diagnosed as pharyngeal binding membrane fever, herpetic pharyngitis, suppurative tonsillitis, etc.; (2) Patient with influenza complications,such as sinusitis, otitis media, bronchitis and pneumonia; (3) Antiviral drugs were used within 48 hours before the visit; (4) Received influenza vaccine within 12 months prior to the start of the trial; (5) Recieving systemic steroid therapy or other immunosuppressive therapy; (6) Patient has history of epilepsy or febrile convulsion; (7) Severe malnutrition, rickets and severe primary diseases of the heart, brain, liver, kidney and hematopoietic system; (8) Allergic to the ingredients of experimental drugs; (9) according to the judgment of the researcher, other diseases or conditions, such as unstable living environment and inconvenient transportation, which may reduce the possibility or complicate the inclusion, may easily lead to loss of access.

Design outcomes

Secondary

Measure	Time frame
Curative effect of TCM syndrome;Time to Resolution of Fever;Rate of complications/severe/critical case;Area under the curve of CARIFS score and time;Individual symptom disappearance rate;	—

Primary

Measure	Time frame
Clinical recovery time;	—

Countries

China

Contacts

Public ContactSiyuan HU

husiyuan1963@sina.com022-27986262

Outcome results

None listed

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