A multi-center, randomized, double-blind, placebo-controlled clinical trial for modified Bushen Yiqi granule in intervention of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)with lung and kidney qi-deficiency and stasis-heat syndrome

A multi-center, randomized, double-blind, placebo-controlled clinical trial for modified Bushen Yiqi granule in intervention of acute exacerbation of chronic obstructive pulmonary disease with lung and kidney qi-deficiency and stasis-heat syndrome

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900023364

Enrollment

Unknown

Registered

2019-05-24

Start date

2019-06-01

Completion date

Unknown

Last updated

2021-01-18

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 + 5days of prednisone + 4 days of prednisone placebo + Modified Bushen Yiqi Fang granules placebo

2:Basic treatment + 5 days of prednisone + 4 days of prednisone placebo + Modified Bushen Yiqi Fang granules

3:Basic treatment + 9 days of prednisone + Modified Bushen Yiqi Fang granules placebo

4:basic treatment + 9 days of prednisone + Modified Bushen Yiqi granules

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40 to 90 years, the gender is not limited; 2. Weight 45-85 kg; 3. Modern medical diagnosis is COPD, the stage is acute exacerbation, and the clinical grade is I-II, inpatients who need hormones; 4. TCM syndrome differentiation is a patient with lung and kidney qi deficiency and syndrome of heat or (and) blood stasis; 5. Subjects volunteered to participate in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with bronchial asthma, bronchiectasis, active tuberculosis, pulmonary infection, pulmonary fibrosis, pneumothorax, pleural effusion, pulmonary embolism, neuromuscular disease affecting respiratory function; 2. Patients with malignant tumors; 3. Leukemia, aplastic anemia, myelodysplastic syndrome, thrombocytopenia, multiple myeloma and other blood diseases. 4. Pregnant or planning pregnant or lactating women; 5. Patients with rheumatic immune diseases, adrenal insufficiency, patients requiring hormones, immunosuppressants; 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. Those who have participated in other drug clinical trials within 3 months; 8. Other circumstances that the investigator believes are not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Lung function;CAT;Blood gas analysis;Time to next exacerbation within 180days;	—

Secondary

Measure	Time frame
mMRC dyspnea scale;TCM syndrome score;	—

Countries

China

Contacts

Public ContactDong Jingcheng, Lyu Yubao

Huashan Hospital Affiliated to Fudan University

dongjc2016@126.com+86 13601761761; +86 13671975272

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026