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

NCT07403032 | Not Yet Recruiting

• 1 other identifier: 2025PHB449-001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

acute exacerbation of chronic obstructive pulmonary disease; modified Ma Xing Shi Gan Decoction

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay (days)

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

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

Secondary Outcomes (6)

• Traditional Chinese Medicine symptom score

  collected at baseline, 7 days, and 14 days post-treatment

• Dyspnea assessment

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

• Mechanical Ventilation Requirement Rate

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

• 6-Minute Walk Test Distance

  Measured at baseline, 7 days, and 14 days.

• Complete blood count (CBC)

  Collected at baseline, 7 days, and 14 days.

Study Arms (2)

test group

EXPERIMENTAL

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: modified Ma Xing Shi Gan Decoction; 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

control group

ACTIVE COMPARATOR

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

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

Interventions

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.

test group

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.

control group; test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Cuiling Feng

CONTACT

010-88325882; fengcuiling@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 11, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 11, 2026

Record last verified: 2025-07