Clinical study of TCM delaying adverse progression in patients with COPD at stable stage (GOLD stage 0-2)

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003920

Enrollment

Unknown

Registered

2020-09-10

Start date

2020-09-10

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

Stable stage of chronic obstructive pulmonary disease (GOLD stage 0-2)

Interventions

Control group :Placebo + Conventional Western Medicine Treatment

Experimental group :Conventional western medicine treatment + Renshen Gejie San

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Stable patients clinically diagnosed as COPD GOLD stage 0-2;In line with the traditional Chinese medicine lung kidney qi deficiency syndrome. 2. There was no history of acute exacerbation in the first 4 weeks of randomization. 3. Successful pulmonary function measurement. 4. The patient was informed and signed a written consent.

Exclusion criteria

Exclusion criteria: 1. The subject is pregnant, breastfeeding or planning to become pregnant; 2. Active pulmonary infection <= 4 weeks after completion of antibiotic and/or steroid therapy or prior pulmonary infection. 3. Combined with other known serious lung diseases, including active tuberculosis, clinically significant bronchiectasis, bronchial asthma, lung cancer, pneumothorax, etc.; 4. Patients with type 1 or type 2 diabetes; 5. Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder neck obstruction or severe renal impairment or urinary retention.Stable treatment in patients with benign prostatic hyperplasia (BPH) may be considered for inclusion. 6. Patients with severe primary diseases such as heart, liver, kidney and hematopoietic system, mental illness or any other disease that may threaten the safety of patients, interfere with the evaluation or hinder the completion of the study; 7. A patient who is allergic to any study drug or similar chemically classified drug; 8. Patients unable to successfully use dry powder inhalers or unable to perform pulmonary function measurements; 9. Are participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
FVC;FEV1;FEV1% expected value case; FEV1 / FVC % expected value;	—

Secondary

Measure	Time frame
CCQ;TCM symptom score scale;mMRC;CAT;SGRQ;	—

Countries

China

Contacts

Public ContactQingsong Huang

Chengdu University of Traditional Chinese Medicine

hqs1261@126.com+86 18981885802

Outcome results

None listed

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