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NCT Number: NCT07403032

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

modified Ma Xing Shi Gan Decoction

Drug

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.

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

Drug

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 outcomes

  1. Length of Hospital Stay (days)

    Time frame: collected at baseline, 7 days, and 14 days post-treatment.

    Number of days the patient remains hospitalized during the study period.

Secondary outcomes

  1. Traditional Chinese Medicine symptom score

    Time frame: collected at baseline, 7 days, and 14 days post-treatment

    The Traditional Chinese Medicine Syndrome Rating Scale is divided into four severity levels: absent, mild, moderate, and severe. Primary symptoms include cough, sputum volume, sputum characteristics, chest fullness and oppression, and dyspnea. Scores range from 0 (least severe) to 6 (most severe). Secondary symptoms include fever, restlessness, thirst with desire to drink, and urinary and bowel status. Scores range from 0 to 3 based on severity. The sum of these scores constitutes the total score. A higher total score indicates greater severity.

  2. Dyspnea assessment

    Time frame: collected at baseline, 7 days, and 14 days post-treatment.

    mMRC questionnaire

  3. Mechanical Ventilation Requirement Rate

    Time frame: collected at baseline, 7 days, and 14 days post-treatment.

    Data is collected in real-time via the hospital's Electronic Medical Record (EMR) system and the ICU ventilator recording system to calculate Total Mechanical Ventilation Time (TMVT). This is further analyzed to distinguish Invasive Mechanical Ventilation Time (IMVT) and Non-Invasive Mechanical Ventilation Time (NIMVT).

  4. 6-Minute Walk Test Distance

    Time frame: Measured at baseline, 7 days, and 14 days.

  5. Complete blood count (CBC)

    Time frame: Collected at baseline, 7 days, and 14 days.

  6. C-reactive protein (CRP)

    Time frame: collected at baseline, 7 days, and 14 days post-treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Cuiling Feng

CONTACT

[email protected]

010-88325882

Sponsors and collaborators

Lead sponsor

Cuiling Feng

Other

Collaborators

  • Linfen Central Hospital
  • Qingyang hospital of traditional Chinese medicine, Gansu Province
  • Traditional Chinese Medicine Hospital of Changji Hui Autonomous Prefecture, Xinjiang
  • Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

Registry information

Official study 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"

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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