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Evaluation of Clinical Efficacy of Pneumonia Qingjie Recipe in Treating Community-Acquired Pneumonia (Non-Severe) with Phlegm-Heat Stagnation of Lung

Evaluation of Clinical Efficacy of Pneumonia Qingjie Recipe in Treating Community-Acquired Pneumonia (Non-Severe) with Phlegm-Heat Stagnation of Lung

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003626
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
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

Community acquired pneumonia, CAP

Interventions

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 2.1 diagnosis and inclusion criteria 2.1.1 diagnostic criteria of western medicine: refer to Chinese medical association's guideline for basic diagnosis and treatment of adult community-acquired pneumonia (2018) and CURB-65 scoring system. Diagnostic criteria of community-acquired pneumonia (non-severe) in 2.1.1.1 (1) community morbidity. (2) Clinical manifestations related to pneumonia: 1) newly appeared cough, expectoration, or aggravation of symptoms of original respiratory diseases, and purulent sputum with or without chest pain; 2) Fever; 3) Lung solid variant sign and/or wet rale smell;4) white blood cell (WBC) count in peripheral blood was > 10 x10^9/l or = 30 times/min; (3) Systolic pressure = 65 years old. 0 point: low risk, outpatient treatment; 1-2 points: moderate risk, it is recommended to be hospitalized or strictly followed up for treatment outside the hospital; >= 3 points: high risk, should be hospitalized, and some should be referred. 2.1.2 diagnostic criteria of traditional Chinese medicine According to Chinese Medicine Branch of Chinese Medicine Association, Lung Disease Branch of Chinese Medicine Association and Lung Disease Branch of Chinese Medicine Association for Nationalities, "Guidelines for Diagnosis and Treatment of Community-acquired Pneumonia with Traditional Chinese Medicine (Revised Edition 2018)", phlegm-heat obstructing lung syndrome was formulated [6]. Main symptoms: cough, excessive sputum, yellow sputum, white and sticky sputum, chest pain, red tongue, yellow and greasy tongue coating, smooth and rapid pulse. Secondary symptoms: fever, thirst, red face, yellow urine, dry stool and abdominal distention. Diagnosis can be made with two of the main symptoms and secondary symptoms. 2.1.3 inclusion criteria (1) meet the diagnostic criteria of community-acquired pneumonia (non-severe); (2) Those who meet the low and medium risk groups of CAP; (3) It conforms to the syndrome differentiation standard of phlegm-heat obstructing lung; (4) Age from 18 to 65 years old, regardless of gender; (5) The onset time does not exceed 72 hours, and antibiotics are not used; (6) Agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) structural lung disease, diabetes, liver and kidney dysfunction and other basic diseases; (2) Complicated with serious heart, brain, lung, liver, kidney, blood system diseases and mental diseases, such as acute heart failure, acute cerebral hemorrhage, viral hepatitis, hemophilia, etc.; (3) Patients with immunodeficiency or taking immunosuppressant or glucocorticoid in recent 3 months; (4) Other therapeutic drugs such as antibiotics, antiviral drugs and traditional Chinese medicines have been used within 48 hours of treatment; (5) Pregnant and lactating women; (6) Allergic constitution, such as those who have been allergic to more than two drugs or foods, and those who are known to be allergic to the ingredients of this drug and cephalosporins. Having any of the above can be excluded.

Design outcomes

Primary

MeasureTime frame
Clinical pulmonary infection (CPIS) score;Inflammation-related indicators;

Secondary

MeasureTime frame
Time to reach initial treatment effective;-;

Countries

China

Contacts

Public ContactHong Fang

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

15000297742@163.com+86 18917763022

Outcome results

None listed

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