Skip to content

A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of Lianhua Qingke tablets in the treatment of Mycoplasma pneumonia in children

A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of Lianhua Qingke tablets in the treatment of Mycoplasma pneumonia in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078209
Enrollment
Unknown
Registered
2023-11-30
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Mycoplasma pneumonia

Interventions

Experimental group:Basic treatment+Lianhua Qingke tablets
Dosage: Children under 7 years old: 2 tablets/time, 3 times/day
= 7-year-old children: 4 tablets/time, 3 times/day
Control group:Basic treatment+Lianhua Qingke tablets placebo

Sponsors

Hebei Yiling Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Age between 4 and 14 years old (including both ends); 2. Mild patients who meet the diagnostic criteria for Mycoplasma pneumonia in children; 3. Nasopharyngeal swab sampling, rapid detection of Mycoplasma pneumoniae antigen positive (colloidal gold method), or detection of Mycoplasma pneumoniae IgM antibody positive in fingertip blood. Any positive result from both can be selected. 4. The course of the disease is = 24 hours and = 5 days, and the body temperature has reached 37.3 ? or above (under the armpit); 5. Those who meet the differentiation criteria for wind heat invading the lungs in traditional Chinese medicine; 6. The legal guardian of the child or/and themselves voluntarily participate in the study, and the legal guardian agrees and signs an informed consent form (while children aged = 8 need to voluntarily sign an informed consent form).

Exclusion criteria

Exclusion criteria: 1. Meets the diagnostic criteria for refractory or severe Mycoplasma pneumoniae pneumonia; 2. Chest X-ray or CT shows obvious lung tumors or tuberculosis; 3. Patients with acute infectious diseases such as measles and pertussis; 4. Other respiratory diseases such as acute upper respiratory tract infections, bronchial asthma, and bronchial foreign bodies; 5. Children with severe malnutrition and immunodeficiency; 6. Concomitant severe primary diseases such as heart, liver, kidney, digestive and hematopoietic systems; 7. Patients who have participated or are currently participating in clinical trials of other drugs within the past three months; 8. Allergic constitution (individuals who are allergic to Class 2 or more components of the investigational drug); 9. Researchers believe that individuals should not be included in the study.

Design outcomes

Primary

MeasureTime frame
The relief rate of main symptoms (fever, cough, sputum, headache, pharyngeal redness, swelling and pain, each symptom decreases by one level to be relieved, and maintained for more than 24 hours);

Secondary

MeasureTime frame
The effectiveness rate of traditional Chinese medicine syndrome scoring (a 50% decrease in total score is considered effective);The relief rate and duration of major single symptoms (fever, cough, sputum, headache, pharyngeal redness, swelling and pain);The proportion of severe or critical cases of Mycoplasma pneumonia;CRP change value;Changes in immunoglobulins, lymphocyte subpopulations, interleukins, etc;Changes in fecal microbiota;

Countries

China

Contacts

Public ContactCao Ran

Hebei Yiling Hospital

1125443703@qq.com+86 188 3391 3086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 1, 2026