A Randomized Controlled Clinical Trial of Yiqi Qingre Granules in Intervention of Lung and Kidney Qi Deficiency Type in acute exacerbation of COPD

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076259

Enrollment

Unknown

Registered

2023-09-28

Start date

2023-10-01

Completion date

Unknown

Last updated

2023-10-03

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

Conditions

Acute exacerbation of chronic obstructive pulmonary disease

Interventions

1:Basic treatment + Yiqi Qingre Granules, one bag at a time, once in the morning and evening, for 7 days.

2:Basic treatment + Yiqi Qingre Granules placebo, one bag at a time, once in the morning and evening, for 7 days.

Eligibility

Sex/Gender

All

Age

40 Years to 90 Years

Inclusion criteria

Inclusion criteria: ? 40 years old =90 years old, male or female; good verbal communication skills;?45kg = weight =85 kg;?AECOPD was diagnosed according to GOLD guidelines and required hospitalization, with acute onset within 3 days; There was a definite diagnosis of COPD in the previous stable period. The time of acute exacerbation at the time of inclusion was less than 3 days;? Patients whose TCM syndrome is lung and kidney qi deficiency type.? Subjects volunteered to participate in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with cardiac asthma, bronchial asthma, bronchiectasis, active tuberculosis, pulmonary infection, pulmonary fibrosis, pneumothorax, pleural effusion, pulmonary embolism, neuromuscular disease affecting respiratory function, severe AECOPD require admission to the ICU, 2.TCM syndrome differentiation of patients with cold syndrome, 3.Patients with malignant tumor, 4. Leukemia, aplastic anemia, myelodysplastic syndrome, thrombocytopenia, multiple myeloma and other blood diseases. 5. Pregnant or planning pregnant or lactating women. 6. Severe impairment of heart, liver and kidney function:(Heart function 3-4-degree, ALT and / or AST exceeds 1.5 times than the upper limit of normal, Cr exceeds the upper limit of normal, 7.Patients with rheumatic immune diseases, adrenal insufficiency, patients requiring hormones, immunosuppressants, 8. Those who have participated in other drug clinical trials within 3 months, 9. Other circumstances that the investigator believes are not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
CAT;Lung function;Blood gas analysis;	—

Secondary

Measure	Time frame
mMRC dyspnea scale;TCM syndrome score;HPA axis index;inflammation index;Sputum Culture;	—

Countries

China

Contacts

Public ContactDong Jingcheng

Huashan Hospital Affiliated to Fudan University

jcdong2004@126.com+86 136 0176 1761

Outcome results

None listed

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