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The efficacy of Huagaisan modification in treating phlegm-dampness obstructing the lung type of chronic obstructive pulmonary disease (COPD) under the theory of lung-intestine integrated management and its impact on patients' gut microbiota.

Exploring the Hua-Zhuo-Jie-Du Method for the Treatment of Stable COPD Based on the Lung-Intestine Theory: A Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002496
Enrollment
Unknown
Registered
2025-12-24
Start date
2023-10-27
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 (COPD)

Interventions

Observation group:Conventional Western medical treatment plus Huagai San-based herbal decoction

Sponsors

Hebei Provincial Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet both the TCM and Western medical diagnostic criteria for AECOPD and have moderate to severe disease with 30% < FEV1% pred < 80%; 2. Patients aged between 40 and 80 years old; 3. Non-critically ill patients who are conscious and have oxygen saturation = 90%; 4. Patients with a duration of acute exacerbation < 7 days; 5. Patients who have not used probiotics or prebiotics in the past month; 6. Patients who have voluntarily signed the informed consent form and are willing to cooperate to complete the entire research process.

Exclusion criteria

Exclusion criteria: 1. Critically ill patients with SpO2 = 90% or FEV1% predicted = 30%; 2. Patients with concurrent bronchial asthma, pneumonia, tuberculosis, lung cancer, or other pulmonary diseases; 3. Patients with severe dysfunction or failure of major organs such as heart, liver, or kidneys; 4. Patients with gastrointestinal diseases such as peptic ulcer bleeding or intestinal obstruction, or those allergic to the study medication; 5. Patients who have used corticosteroids, immunosuppressants, or antibiotics within the past 2 weeks; 6. Pregnant or breastfeeding women, or patients with mental illness.

Design outcomes

Primary

MeasureTime frame
Clinical Efficacy Evaluation;

Secondary

MeasureTime frame
Related Exposure Factors;TCM syndrome score;CAT Score;CRP level;Gut microbiota distribution;Adverse Reaction;

Countries

China

Contacts

Public ContactGuo Jie

Hebei Provincial Traditional Chinese Medicine Hospital

823533730@qq.com15931688863

Outcome results

None listed

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