Skip to content

The No.2 Jianpi Yifei in the treatment of patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD): a multicenter, randomised, double-blind, placebo controlled clinical trial

The No.2 Jianpi Yifei in the treatment of patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD): a multicenter, randomised, double-blind, placebo controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008082
Enrollment
Unknown
Registered
2016-03-11
Start date
2016-03-15
Completion date
Unknown
Last updated
2017-04-18

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

Treatment group:Granule of No.2 Jianpi Yifei
Control group:Placebo of No.2 Jianpi Yifei

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. According to COPD criteria defined by GOLD, grade II to IV, and after post-bronchodilators, FEV1% between 20% to 80%; 3. TCM syndrome differentiation is Qi deficiency syndrome or deficiency of Qi; 4. Patients with cough, sputum, dyspnea and other symptoms, these symptoms are stable or slight, for at least 2 weeks; 5. There have been at least one acute exacerbation of patients in the last 1 years; 6. Patients signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with a history asthma, bronchial dilation and so on; 2. Those with a history of chronic systemic infections or inflammatory conditions that required systematic corticosteroid treatment in the last 3 months; 3. TCM syndrome differentiation with Yin deficiency as the main syndrome; 4. Chest imaging shows that there is a lung infection, pulmonary mass, or other features that judged it is not fit into the group; 5. Patients with malignant tumor, diabetes, acute peptic ulcer or bleeding, or other serious diseases, and the researchers estimate that it is not suitable to participate in the study; 6. Those who are not willing to accept the observation measures or because of mental illness can not cooperate; 7. Individuals unable to adequately perform spirometry tests; 8. Those who start taking Jianpi Yifei medicine before 2 weeks in the study, or individuals having pulmonary rehabilitation within three months of the commencement of the study, or intend to enter pulmonary rehabilitation during the study; 9. Pregnancy, breast-feeding or women intending to become pregnant during the course of the study.

Design outcomes

Primary

MeasureTime frame
SGRQ;

Secondary

MeasureTime frame
Frequency of COPD acute exacerbation;Time to first exacerbation;Acute exacerbation rate;Severity of acute exacerbation;6WMT;BODE index;Lung function;CAT;SpO2;

Countries

China

Contacts

Public ContactLin Lin
drlinlin620@163.com+86 13903002015

Outcome results

None listed

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