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

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"

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cuiling Feng; Phone Number: 010-88325882; Email: fengcuiling@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)" ;
2. 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;
3. Age > 18 years;
4. Hospitalized patients;
5. Voluntarily consent to treatment and sign an informed consent form.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; 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; 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.
Active Comparator: control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese Medicine symptom score	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.	collected at baseline, 7 days, and 14 days post-treatment
Dyspnea assessment	mMRC questionnaire	collected at baseline, 7 days, and 14 days post-treatment.
Mechanical Ventilation Requirement Rate	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).	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.
C-reactive protein (CRP)		collected at baseline, 7 days, and 14 days post-treatment.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 12, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: acute exacerbation of chronic obstructive pulmonary disease; modified Ma Xing Shi Gan Decoction
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2025PHB449-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: have not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No