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The clinical trial of Dusu Qing pellet: a phase II study

The clinical trial of evaluation on activity and safety of Dusu Qing pellet in treating elderly the community-acquired pneumonia (phlegm heat indicates lungs and qi and Yin deficiency syndrome) based on antibiotic treatment: a double-blinded, randomed, placebo-controlled II clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005357
Enrollment
Unknown
Registered
2014-10-18
Start date
2014-10-18
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

elderly community-acquired pneumonia

Interventions

treatment:Dusu Qing pellets, 1#, tid.
Control:placebo, 1#, tid.

Sponsors

Institute of Traditional Chinese Medicine of Fujian Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. With the western medicine diagnosis standard of community acquired pneumonia; 2. Meet the standard for TCM Syndromes of phlegm heat obstructing the lung qi and yin deficiency syndrome and two, with the main symptoms of fever, cough etc.; 3. 18-70 years old; 4. Course of the disease shorter than 96 h; 5. TCM syndrome scoring more than 10 points; 6. PORT score: II-IV; 7. Skin test of Fanlin is negative; 8. Subjects agree and sign the consent form.

Exclusion criteria

Exclusion criteria: 1. Allergic constitution or the allergies to known drug; 2. Course of the disease longer than 96 h; 3. Patients considered for suspected atypical pneumonia or viral pneumonia according to the clinical manifestation; 4. In accordance with the guidelines to criteria of severe pneumonia diagnostic; One of the following signs or above can be diagnosed with severe pneumonia: (1)Disturbance of consciousness; (2) Respiratory rate more than 30 breaths/min; (3) PaO2 less than 60mmHg, PaO2/FiO2 less than 300, treated by mechanical ventilation; (4) Systolic blood pressure less than 90mmHg; (5) Complicated with septic shock; (6) Chest X-ray showes lesion expanded moore than 50% in 48h; (7) Oliguria: Urine volume less than 20ml/h, or less than 80ml/4h, or complicated with acute renal failure requiring dialysis treatment; 5. TCM syndrome scoring less than 10 points; 6. The presence of severe interstitial lung disease, bronchiectasis basic lung disease results from thoracic CT examination; And patients with severe chronic obstructive pulmonary disease and inhaled corticosteroids. 7. Abnormal aboratory results: (1) AST more than 1.5ULN and/or ALT more than 1.5ULN; The serum creatinine than the upper limit of normal person; 8. With severe basic diseaseS of cardiovascular, liver, kidney and hematopoietic system. (COPD corticosteroid treatment patients); 9. Patients with malignant solid tumors; 10. After organ transplantation; 11. Psychotic patients; 12. Immune deficiency or patients who are treated by immunosuppressive agent or combined with Glucocorticoid within the past 3 months; 13. Participation in any clinical trial; 14. Any condition associated with poor compliance as judged by the investigator, such as lost to follow-up caused by work or living environment changes frequently.

Design outcomes

Primary

MeasureTime frame
the symptoms disappeared rate (fever, cough) seven days after treatment;the disappear time of Single main symptoms (fever, cough);

Secondary

MeasureTime frame
the bacterial clearance rate;TCM symptom effect;hospitalization time;blood routine;C-reactive Protein;The absorption rate of pneumonia;

Countries

China

Contacts

Public ContactZhibin Chen
bin669@163.com+86 0591-83570943

Outcome results

None listed

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