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Clinical Research on the Treatment of COPD Complicated with Pulmonary Encephalopathy with Modified Xiaoxianxiong Decoction

Clinical Research on the Treatment of COPD Complicated with Pulmonary Encephalopathy with Modified Xiaoxianxiong Decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001018
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-05-21
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD with pulmonary encephalopathy

Interventions

Experimental group:Conventional treatment with Western medicine+Add flavored small chest decoction orally or nasogastric feeding

Sponsors

Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria Meets the diagnostic criteria for COPD in the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition). Symptoms and signs such as cough sputum production wheezing shortness of breath chest tightness and dyspnea; After pulmonary function testing irreversible airflow limitation is determined; Forced expiratory volume/percent forced vital capacity (FEV1/FVC) in 1 second <70%. Meets the diagnostic criteria for pulmonary encephalopathy in Respiratory Medicine. COPD leads to insufficient oxygen levels and CO2 retention in the body and patients develop neurological symptoms such as reduced computing ability memory loss confusion agitation drowsiness and coma. 2. Dialectical criteria Referring to the TCM Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (2011 Edition) the TCM Clinical Diagnosis and Treatment Guidelines for Asthma Syndrome (Chronic Obstructive Pulmonary Disease and Right Heart Failure) and the TCM Internal Medicine the diagnostic criteria for phlegm-heat obstructive pulmonary syndrome were formulated: Main symptoms: (1) abnormal mental status (drowsiness coma delirium irritability); (2) wheezing; (3) The sputum is yellow and sticky and the cough is unpleasant or the sputum is bloody. Secondary symptoms: (1) cough; (2) constipation; (3) bloating; (4) Edema of the face or lower limbs. Tongue and vein: the tongue is red the tongue coating is yellow or thick and the pulse is smooth or sinking. It can be diagnosed by combining the tongue and pulse pattern with 2 of the 2 major symptoms and the second of the secondary symptoms. Scoring Criteria for TCM Syndromes: According to the Guiding Principles for Clinical Research of New Drugs in Chinese Medicine (2002 Edition) Formulate scoring criteria and divide them into none light medium and heavy grades. The main symptoms are 0 2 4 6 points; Secondary symptoms are scored on a scale of 0 1 2 and 3 (Schedule 1). 3. Inclusion criteria Meet the above diagnostic and syndrome differentiation criteria; Patients or family members agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients with interstitial pneumonia lung cancer bronchial tension bronchial asthma and other lung diseases; Patients with immunodeficiency diseases hematologic diseases liver and kidney failure; Patients with cognitive dysfunction caused by mental disorders cerebrovascular accidents hepatic encephalopathy and other diseases.

Design outcomes

Primary

MeasureTime frame
GCS score;TCM Syndrome Points;

Secondary

MeasureTime frame
Arterial blood gas analysis (PH PaO2 PaCO2);Duration of mechanical ventilation;Inflammatory markers (leukocytes neutrophils procalcitonin C-reactive protein interleukin-6);Rate of endotracheal intubation;

Countries

China

Contacts

Public ContactZhang Hairong

Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine

zhramanda@163.com18247129736

Outcome results

None listed

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