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Multicenter prospective randomized controlled trial for Dong-Tian Chang-Chun Ointment in the treatment of stable COPD patients

Multicenter prospective randomized controlled trial for Dong-Tian Chang-Chun Ointment in the treatment of stable COPD patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030452
Enrollment
Unknown
Registered
2020-03-02
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-03-09

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

Zhongshan Hospital Affiliated Fudan University ; Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the western medicine diagnosis, classification, and stage diagnosis are included patients; 2. History of 1 to 3 acute exacerbations in the past 12 months; 3. Aged 40 to 80 years; 4. The syndrome differentiation of TCM belongs to the syndrome of deficiency of lung qi, deficiency of lung and spleen, deficiency of lung and kidney, and deficiency of both lung and kidney; 5. Voluntarily receive treatment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the above-mentioned western medical diagnosis, staging diagnosis and traditional Chinese medicine diagnosis standards; 2. Examination confirms chronic cough caused by tuberculosis, fungi, tumors, irritating gas allergies and other factors; 3. Patients with other respiratory diseases that can cause asthma or dyspnea; 4. pregnant or lactating women, allergic to Symbio 9ug / 320ug and Dongtian Changchun cream; 5. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental illness; 6. Concurrent severe heart dysfunction; 7. Contains factors that affect the observation of efficacy; 8. Those who do not meet the inclusion criteria, fail to use the drug as prescribed, cannot determine the efficacy or incomplete data, etc., which affect the efficacy or safety judgment; 9. Those who are participating in other clinical trials within 1 month before enrollment; 10. Patients with diabetes.

Design outcomes

Primary

MeasureTime frame
Number of acute attacks;TCM Syndrome Effect;SGRQ;

Secondary

MeasureTime frame
pulmonary function;6MWT;mMRC;Single-cell gene sequencing and mass spectrometry examination;

Countries

China

Contacts

Public ContactZHANG WEI

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

zhangw1190@sina.com+86 13023153956

Outcome results

None listed

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