Study on metabonomics of Chinese herbal medicine in the treatment of type 2 diabetes mellitus complicated with community-acquired pneumonia

Phase 1

Not yet recruiting

• Conditions: type 2 diabetes mellitus complicated with community-acquired pneumonia

• Registration Number: ITMCTR2000003540
• Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion criteria for T2DM-CAP group
1. Participants have a history of type 2 diabetes and are hospitalized with confirmed CAP.
2. Participants meet the criteria for pulmonary-splenic asthenia and accumulation of phlegm-dampness syndrome in TCM.
3. Participants Participants aged 18–70 years, no gender limitations.
4. Participants can complete this study and all tests.
5. Participants provide informed written consent and volunteer to participate in the trial.

Inclusion criteria for T2DM group:
1. Patients who meet the diagnostic criteria of diabetes, that is, the fasting blood glucose level is greater than or equal to 7.0 mmol / L, and the postprandial blood glucose is greater than or equal to 11.1 mmol / L.
2. Participants Participants aged 18–70 years, no gender limitations.
3. Participants provide informed written consent and volunteer to participate in the trial.

Inclusion criteria for CAP group
1. Patients who meet the diagnostic criteria of CAP.
2. Participants Participants aged 18–70 years, no gender limitations.
3. Participants provide informed written consent and volunteer to participate in the trial.

Exclusion Criteria

Exclusion criteria for T2DM-CAP group
1. Patients with other coexistent pulmonary diseases (e.g., bronchiectasis,pulmonary edema, chronic obstructive pulmonary disease, tuberculosis, or interstitial lung disease).
2. Patients with severe comorbidities, such as malignant tumors, infectious diseases, coronary heart disease, mental abnormality or patients whose laboratory data indicating severe systemic disease (such as liver and kidney dysfunction).
3. Patients complicated with other infectious diseases;
4. Women who are breastfeeding, or pregnant.
5. Allergies for experimental drugs or Chinese herbal medicine.
6. Patients have participated in other clinical trials in the one month preceding the trial.

Exclusion criteria for T2DM group
1. Combined with CAP, tuberculosis and other infectious diseases;
2. Patients with severe comorbidities, such as malignant tumors, infectious diseases, coronary heart disease, mental abnormality or patients whose laboratory data indicating severe systemic disease (such as liver and kidney dysfunction).
3. Women who are breastfeeding, or pregnant.
4. Patients with acute metabolic disorders such as diabetic ketoacidosis in the past month.

Exclusion criteria for CAP group
1. Ccomplicated with other lung diseases (COPD, pulmonary tuberculosis, bronchial asthma, etc.).
2. Complicated with diabetes.
3. patients with severe complications, such as malignant tumors, infectious diseases, coronary heart disease, mental disorders or laboratory data show severe systemic diseases (such as hepatorenal dysfunction).
4. Women who are breastfeeding, or pregnant.
5. Complicated with other infectious diseases.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Total clinical effective rate of pneumonia;

Secondary Outcome Measures

Name	Time	Method
TCM symptom score scale;Frequency of hypoglycemia;HbA1c;Time required for pneumonia control;blood glucose;Time required for blood glucose to reach standard;Inflammatory biomarkers;chest CT;Differences in blood metabolomics;