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Jianpi Shufei Granule for Early-stage Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Placebo-controlled Trial

Jianpi Shufei Granule for Early-stage Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Placebo-controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005359
Enrollment
Unknown
Registered
2021-11-30
Start date
2021-11-30
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Control group:placebo
Experimental group:Jian Pi Shu Fei granules

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: ?Patients who are aged 40–85 years; ?Patients who meet the diagnostic criteria of COPD, stage I-II, with stable stage; ?Patients who meet the Chinese medicine syndrome classification of Qi deficiency and phlegm obstruction; ?Patients who sign the written informed consent form.

Exclusion criteria

Exclusion criteria: ?Patients with asthma,bronchiectasis,obstructive sleep apnea syndrome,lung malignant tumors or active pulmonary tuberculosis;?Chinese medicine syndrome based on Yin deficiency;?Patients with acute exacerbation of COPD within 4 weeks before enrollment;?Patients with history of allergies or hypersensitivity for any research drug component, or the researcher believes that it is known to have a disease that should not be participated in research;?Those who cannot complete the lung function test; ?Long-term of traditional Chinese medicine diet (astragalus, ginseng) and other Chinese medicinal materials);?Patients with severe cardiovascular, cerebrovascular, liver and kidney disease;?Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or serum creatinine (Scr) exceed 1.5 times the upper limit of normal value;?Poor compliance;?Patients who have received any experimental drug treatment within 1 month;?Patients who Participated in or plan to participate in other clinical trials.

Design outcomes

Primary

MeasureTime frame
CAT;

Secondary

MeasureTime frame
Acute exacerbation per year;Safety;BODE;Time to first exacerbation;mMRC;CCQ;6MWT;CASA;lung function;

Countries

China

Contacts

Public ContactLin Lin
drlinlin620@163.com81887233-38605

Outcome results

None listed

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