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Not yet recruiting NCT07403032

Study on the Effects and Mechanisms of Modified Ma Xing Shi Gan Decoction in Treating Acute Exacerbations of Chronic Obstructive Pulmonary Disease

No phase Interventional Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: modified Ma Xing Shi Gan Decoction, The specific drug comes from "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Revised Edition 2023)" and the GOLD guidelines.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study on the Effects and Mechanisms of Modified Ma Xing Shi Gan Decoction in Treating Acute Exacerbations of Chronic Obstructive Pulmonary Disease Based on the "Lung-Large Intestine Mutual Interior-Exterior Relationship"

Overview

This study adopted a multi-center, randomized, controlled trial design. Patients with acute exacerbation of chronic obstructive pulmonary disease who met the inclusion criteria were randomly assigned to the experimental group and the control group. Both groups were treated under the guidance of the "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" and the GOLD guidelines. The experimental group was treated with modified Maxing Shigan Decoction. The modified Ma Xing Shi Gan Decoction was administered twice a day for 14 days. Taking the length of hospital stay (days) of the patients as the primary efficacy indicator, and the TCM syndrome score, dyspnea score (mMRC), 6-minute walk test and mechanical ventilation demand rate as the secondary efficacy indicators, the clinical efficacy of modified Maxing Shigan Decoction in the treatment of acute exacerbation of chronic obstructive pulmonary disease was evaluated.

Interventions

  • Drug modified Ma Xing Shi Gan Decoction
    The patient was given basic Western medical treatment combined with modified Ma Xing Shi Gan Decoction, orally twice a day for 14 days of intervention.
  • Drug The specific drug comes from "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Revised Edition 2023)" and the GOLD guidelines
    Under the guidance of the "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" and the GOLD guidelines, basic Western medical treatment was given. The main types include third-generation cephalosporins, expectorants, short-acting anticholinergic drugs, and short-acting β2 receptor agonists, etc.

Primary outcome measures

  • Length of Hospital Stay (days) [Time frame: collected at baseline, 7 days, and 14 days post-treatment.]
Secondary outcome measures (6)
  • Traditional Chinese Medicine symptom score [Time frame: collected at baseline, 7 days, and 14 days post-treatment]
  • Dyspnea assessment [Time frame: collected at baseline, 7 days, and 14 days post-treatment.]
  • Mechanical Ventilation Requirement Rate [Time frame: collected at baseline, 7 days, and 14 days post-treatment.]
  • 6-Minute Walk Test Distance [Time frame: Measured at baseline, 7 days, and 14 days.]
  • Complete blood count (CBC) [Time frame: Collected at baseline, 7 days, and 14 days.]
  • C-reactive protein (CRP) [Time frame: collected at baseline, 7 days, and 14 days post-treatment.]

Eligibility criteria

Inclusion criteria

  • Patients meeting diagnostic criteria for COPD exacerbation, as defined by "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" ;
  • Patients meeting the diagnostic criteria for phlegm-heat stagnation in the lungs syndrome within COPD, as referenced in the "Clinical Diagnosis and Treatment Terminology of Traditional Chinese Medicine: Syndromes" and the 2020 International Guidelines for Clinical Practice of Traditional Chinese Medicine;
  • Age > 18 years;
  • Hospitalized patients;
  • Voluntarily consent to treatment and sign an informed consent form.

Exclusion criteria

  • History of allergy to the study drug;
  • History of active liver disease;
  • Patients undergoing dialysis or with known moderate to severe renal impairment;
  • Suspected or confirmed active systemic infection;
  • Patients with host immune dysfunction, host immunodeficiency, or host immune reconstitution.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07403032 · 2025PHB449-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗