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Randomized controlled clinical trial of Qingke Pingchuan granule in the treatment of adult community-acquired pneumonia

Randomized controlled clinical trial of Qingke Pingchuan Granule in the treatment of adult community-acquired pneumonia (phlegm-heat blocking lung syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083218
Enrollment
Unknown
Registered
2024-04-18
Start date
2024-04-22
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Community-acquired pneumonia

Interventions

Experimental group:Taking Qingke Pingchuan Granule on the basis of basic treatment of western medicine.
Control group:According to "Guidelines for Diagnosis and Treatment of Adult Community-acquired Pneumonia in China (2016 Edition)", basic treatment was given to western medicine (using ß -lactam antibi

Sponsors

Jiangsu shengze hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 and < 65 years old, regardless of sex; (2) According to the "Guidelines for Diagnosis and Treatment of Adult Community-acquired Pneumonia in China (2016 Edition)", it conforms to the clinical diagnosis of community-acquired pneumonia; (3) According to the Guide of TCM Diagnosis and Treatment of Community-acquired Pneumonia (2011 Edition), TCM syndrome differentiation belongs to phlegm-heat blocking lung syndrome; (4) Severity of 4)CAP: CURB-65 score is 0-2; (5) The onset time is less than 72 hours; (6) Sign the informed consent form voluntarily, and fully understand the test content, process and possible adverse reactions.(Syndrome of phlegm-heat obstructing the lung: the main symptoms are cough, excessive phlegm, yellow phlegm, white and sticky phlegm, chest pain, red tongue, yellow and greasy tongue coating, slippery and rapid pulse. The secondary symptoms are fever, thirst, flushed face, yellow urine, dry stool and abdominal distension. )

Exclusion criteria

Exclusion criteria: (1) patients who meet the standard of severe pneumonia; (2) Complicated with other respiratory diseases, such as chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, active tuberculosis and other primary lung diseases; (3) accompanied by serious or uncontrollable underlying diseases: such as hematological diseases; Hepatic insufficiency (ALT or AST=3ULN, total bilirubin =1.5ULN), renal insufficiency (serum creatinine > 177 µ mol/L or 2mg/dL), chronic congestive heart failure (NYHA III-IV); Immunodeficiency, such as malignant tumor, organ or bone marrow transplantation, HIV infection or taking immunosuppressants in recent 3 months; (4) those who suspect or have a history of alcohol, drug abuse or mental illness; (5) Dysphagia or any history of gastrointestinal diseases affecting drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, after subtotal gastrectomy, etc.); (6) allergic constitution, or those who are known to be allergic to the ingredients of Qingke Pingchuan Granules and to basic therapeutic drugs; (7) Subjects took the study drug orally within one month before entering the group; (8) Pregnant, planned pregnancy and lactating patients; (9) According to the judgment of the researcher, there are other circumstances that are not suitable for participating in this experiment.

Design outcomes

Primary

MeasureTime frame
Clinical effective rate;

Secondary

MeasureTime frame
Imaging absorption evaluation of pneumonia;Cough score;Proportion and time of cough disappearance;Proportion and time of expectoration disappearing;Cough and expectoration assessment questionnaire;CURB-65 score;Inflammation index;

Countries

China

Contacts

Public ContactSonglili

Jiangsu shengze hospital

sll6035@163.com+86 189 0625 6035

Outcome results

None listed

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