Yinma Jiedu granules for patient with community-acquired pneumonia: a multicenter, randomized, double-blind, placebo-parallel controlled clinical trial

Phase 1

Recruiting

• Conditions: Community-acquired pneumonia

• Registration Number: ChiCTR2300072343
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged from 18 to 80 years; <br>2. Meet the diagnostic criteria in guidelines for the diagnosis and treatment of community-acquired pneumonia in Chinese adults (2016 Edition); <br>3.TCM syndrome differentiation meet the diagnostic criteria about the wind heat attacking lung syndrome or phlegm-heat obstructing lung syndrome in TCM diagnosis and treatment guidelines for community acquired pneumonia (2018 Revised Edition); 4.The clinical symptoms of the subject should be at least 2 of the following 4 main symptoms: cough, sputum, dyspnea (shortness of breath), pleurisy chest pain; <br>5. CURB-65 score was 0-2; <br>6. Voluntary signing of informed consent.

Exclusion Criteria

1. Severe CAP patients; <br>2. Interstitial pneumonia, hospital acquired pneumonia (including ventilator-associated pneumonia); <br>3. Patients with serious complications such as lung abscess, atelectasis and empyema; <br>4. Patient complicated with other serious respiratory diseases, such as chronic obstructive pulmonary disease, bronchiectasis, and active tuberculosis; <br>5. Patient complicated with serious underlying diseases such as heart, brain, liver, kidney, blood system and mental diseases; <br>6. Patients who continuously took Chinese herbal medicine, Chinese patent medicine that had the effect of clearing heat and reducing phlegm and relieving cough or had the antibacterial effect clearly defined by modern pharmacology within 48 hours before enrolled;<br>7. Liver function (ALT, AST) or renal function (serum creatinine) exceeding 2 times the upper limit of normal; <br>8. TCM syndrome differentiation of spleen and stomach weakness is manifested as one of the following three conditions: ? epigastric distension or dull pain, stomach preference for warm, loose stools, fatigue, weak tongue, tooth marks on the side; ?gastric epigastric fullness, aggravated by cold, noisy acid reflux, dry mouth and bitter mouth, cold limbs and loose stool; ?loose stool when diarrhea, the diet is slightly careless that hair or aggravate, weak tongue; <br>9. Patients with diseases that seriously affect the immune system, such as malignant tumors, organ or bone marrow transplantation, HIV infection, or who have taken immunosuppressants or systemic glucocorticoids within the last 3 months; <br>10. Patients with dysphagia or a history of gastrointestinal diseases that affect the absorption of test drugs (including but not limited to chronic diarrhea, reflux esophagitis, ulcerative colitis, intestinal tuberculosis, gastrinoma, short bowel syndrome, postsubtotal gastrectomy, etc.); <br>11. Patients with diabetes mellitus, unstable blood glucose control, and HBA1c control target > 7%;<br>12. Having a history of drug addiction or drug abuse; <br>13. Pregnancy, planned pregnancy or lactation women; <br>14. Patients with severe allergic reaction, or known allergic history to Yinma Jiedu granules or placebo ingredients; <br>15. Patients who have participated in or are participating in other clinical trials within the last 3 months; <br>16. Patients' compliance is considered by the investigator to be poor and difficult to complete or comply with the requirements of this experiment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical symptom improvement rate in day 4;

Secondary Outcome Measures

Name	Time	Method
Clinical cure rate;Improvement rate of single symptom (including cough, phlegm, pleurisy pain, dyspnea) ;Cough and Sputum Assessment Questionnaire (CASA-Q);Improved pneumonia Imaging Absorption Evaluation scale;CURB-65 rating;Changes in inflammatory markers (C-reactive protein, procalcitonin, interleukin 6, serum amyloid A) ;TCM syndrome score;Improvement rate of TCM syndromes;Antibiotic dosage and duration;The amount of emergency medication used;