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Effect of Jianpiyifei II granule on patients with mild to moderate Chronic Obstructive Pulmonary Disease (COPD): a randomized controlled clinical trial

Effect of Jianpiyifei II granule on patients with mild to moderate Chronic Obstructive Pulmonary Disease (COPD): a randomized controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031907
Enrollment
Unknown
Registered
2020-04-14
Start date
2020-04-20
Completion date
Unknown
Last updated
2020-04-20

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

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40 to 85 years, both men and women; 2. A diagnosis of mild to moderate COPD which defined by the GOLD Guidelines as post-bronchodilator FEV1/FVC = 50% predicted value; 3. Stable COPD before screening, that is, no acute exacerbation at least 4 weeks prior to trial entry and no hospitalization for exacerbation in the past 3 months; 4. TCM syndrome differentiation is Qi deficiency syndrome or Qi deficiency is the main syndrome; 5. patients signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Had a history of asthma, bronchiectasis, lung cancer, active pulmonary tuberculosis and pneumonectomy; 2. Experienced frequent acute exacerbations (>=3 times) of COPD in the past year; 3. Had a blood eosinophil count >= 300/µL; 4. Frequent oral or intravenous corticosteroids (prednisone >10 mg/day); 5. TCM syndrome differentiation is excess syndrome and heat Syndrome; 6. Those who are not willing to accept the observation measures or can not cooperate because of mental illness; 7. Those who cannot complete the lung function test; 8. Those who took herbal medicines for strengthening the spleen and benefiting the lungs two weeks before the trial, or those who had undergone lung rehabilitation within three months, or planned to undergo lung rehabilitation during the study.

Design outcomes

Primary

MeasureTime frame
Lung function;

Secondary

MeasureTime frame
CAT;SGRQ;6-MWT;BODE index;mMRC;Frequency of COPD acute exacerbation;

Countries

China

Contacts

Public ContactYuanbin Chen

Guangdong Provincial Hospital of Chinese Medicine

chenyuanbin110@163.com+86 15920174645

Outcome results

None listed

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