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A randomized double-blind very low-dose parallel-controlled multi-center phase II clinical trial of Lanqin oral solution for the treatment of acute pharyngitis in children (pulmonary and gastric heat syndrome)

A randomized double-blind very low-dose parallel-controlled multi-center phase II clinical trial of Lanqin oral solution for the treatment of acute pharyngitis in children (pulmonary and gastric heat syndrome)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001412
Enrollment
Unknown
Registered
2025-07-16
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Acute pharyngitis in children

Interventions

Control group:10% Lanqin oral liquid oral. 3= age = 6 years old 0.5 vials (5ml) at a time one day 3 times
6< age= 12 years old 1 bottle (10ml) at a time 3 times a day
Experimental group:Lanqin oral liquid oral. 3= age = 6 years old 0.5 sticks (5ml) at a time 3 times a day

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for acute pharyngitis. (2) Meets the traditional Chinese medicine differentiation criteria for lung stomach heat syndrome. (3) Age range from 3 to 12 years old (<13 years old). (4) Randomly enrolled with a disease duration of = 48 hours and a Wong Baker facial expression pain score (WBS) of = 4 for the most severe sore throat within the day prior to screening. (5) The informed consent process should comply with regulations and the legal guardian or participant (= 8 years old) should jointly sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Acute pharyngitis caused by non infectious factors such as dust smoke and irritant gases acute suppurative tonsillitis (acute follicular tonsillitis and acute crypt tonsillitis) grade III tonsillar enlargement peritonsillar abscess or posterior pharyngeal wall abscess and pharyngeal symptoms caused by other diseases. (2) Individuals who test positive for rapid streptococcal antigen. (3) The white blood cell count absolute neutrophil count and CRP all exceeded the upper limit of normal (ULN) by 1.2 times and the researchers considered it to be a bacterial infection or the need for antibiotic treatment. (4) The prodromal or accompanying symptoms of acute infectious diseases such as measles scarlet fever infectious mononucleosis etc. (5) Children with complications such as acute pharyngitis otitis media bronchitis pneumonia etc. (6) Abnormal liver and kidney function [AST ALT Scr>upper limit of normal] evaluated by researchers as clinically significant. (7) Individuals with severe primary diseases of the heart lungs liver kidneys metabolism hematopoiesis immune nervous and psychiatric systems. (8) Children or their parents/caregivers who have difficulty understanding or cannot cooperate with the use of WBS scoring. (9) Those who have used traditional Chinese and Western medicine drugs to treat this disease 48 hours before diagnosis and have been judged by researchers to have an impact on the evaluation of therapeutic efficacy. (10) Individuals who are allergic to the experimental medication and its components. (11) Individuals who have participated in or are currently participating in other clinical trials and have received investigational drug treatment within the past 3 months prior to the trial. (12) Researchers believe that participants should not be included in the study.

Design outcomes

Primary

MeasureTime frame
Sore throat disappearance rate after 5 days of medication;

Secondary

MeasureTime frame
TCM Pattern Score/Efficacy (Effective);Sore throat WBS score;Efficacy of pharyngeal signs (rate of normalization);Time for the sore throat to disappear;Onset of action for sore throat;Disease efficacy (recovery rate);Use of emergency medications;Efficacy of individual symptoms (disappearance rate);

Countries

China

Contacts

Public ContactPing Rong

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

erke2007@163.com13820862076

Outcome results

None listed

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