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Construction of an integrated TCM and Western medicine management model for COPD based on the principle of tonifying Qi, activating blood and resolving phlegm

Construction of an integrated TCM and Western medicine management model for COPD based on the principle of tonifying Qi, activating blood and resolving phlegm

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002615
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

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

Experimental Group:Yihuo Huatan Formula Instant decoction
Control Group:Yihuo Huatan Formula Instant placebo

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: **Study 1 Inclusion Criteria:** 1. Presence of risk factors for COPD. 2. History of chronic bronchitis and/or emphysema, with at least one of the following symptoms: - Cough; - Sputum production; - Dyspnea. 3. Pulmonary function test results meeting the following criteria: - FEV1/FVC = 70%, and - FEV1% < 80%. 4. Consistent with the syndrome of qi deficiency, blood stasis, and phlegm turbidity. 5. Age between 18 and 65 years. 6. Voluntary participation in the study and signing of the informed consent form. **Study 2 Inclusion Criteria:** 1. Age between 40 and 80 years. 2. In the stable phase of COPD. 3. Traditional Chinese medicine diagnosis corresponds to Qi deficiency, blood stasis, and phlegm-dampness syndrome. 4. Voluntary participation in the study and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Women in pregnancy, planning pregnancy, or lactation; (2) Patients with dementia or various mental illnesses; (3) Patients suffering from other conditions that cause chronic cough, phlegm production, or breathing difficulties; (4) Patients with comorbidities such as tumors, severe cardiovascular diseases, severe liver or kidney diseases, or severe hematological disorders; (5) Individuals currently participating in other clinical trials of medications; (6) Patients allergic to the intervention drugs; (7) Patients deemed unsuitable for participation in this clinical trial by the investigators.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine symptom efficacy;Annual acute exacerbation frequency;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Scoring;Pulmonary Function;COPD Assessment Test;modified Medical Research Council Dyspnea Scale;Clinical COPD Questionnaire;Saint George's Respiratory Questionnaire;Hospital Anxiety and Depression Scale;Incidence rate of COPD;First acute exacerbation time;The incidence rate of acute respiratory infections;6-minute walking distance;

Countries

China

Contacts

Public ContactBing Mao

West China Hospital Of Sichuan University

maobing@medmail.com.cn18980601724

Outcome results

None listed

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