Chronic Obstructive Pulmonary DiseaseNCT07403032
Study on the Effects and Mechanisms of Modified Ma Xing Shi Gan Decoction in Treating Acute Exacerbations of Chronic Obstructive Pulmonary Disease
A study testing modified Ma Xing Shi Gan Decoction and 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 in people with Chronic Obstructive Pulmonary Disease, run by Cuiling Feng.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- modified Ma Xing Shi Gan Decoction and 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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"
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
- Being tested
- 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
- Keywords
- acute exacerbation of chronic obstructive pulmonary disease, modified Ma Xing Shi Gan Decoction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Ma Xing Shi Gan DecoctionDrug
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 guidelinesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay (days)
Number of days the patient remains hospitalized during the study period.
Measured: collected at baseline, 7 days, and 14 days post-treatment.
Secondary outcomes (6)
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.
Measured: collected at baseline, 7 days, and 14 days post-treatment
Dyspnea assessment
mMRC questionnaire
Measured: 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).
Measured: collected at baseline, 7 days, and 14 days post-treatment.
6-Minute Walk Test Distance
Measured: Measured at baseline, 7 days, and 14 days.
Complete blood count (CBC)
Measured: Collected at baseline, 7 days, and 14 days.
C-reactive protein (CRP)
Measured: collected at baseline, 7 days, and 14 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start12 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cuiling Feng
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Cuiling Feng, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403032
- Sponsor's protocol ID
- 2025PHB449-001
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: have not decided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT07403032
- Acronym / sponsor ID
- 2025PHB449-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- acute exacerbation of chronic obstructive pulmonary disease, modified Ma Xing Shi Gan Decoction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cuiling FengUniversity, hospital or other
- 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 start
- 12 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | 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 guidelinesThe patient was given basic Western medical treatment combined with modified Ma Xing Shi Gan Decoction, orally twice a day for 14 days of intervention. |
| control group | Active comparator | 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 guidelinesUnder 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Ma Xing Shi Gan DecoctionThe 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 | 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 guidelinesUnder 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. | Drug | control group, test group |
Primary outcome
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.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided. have not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing modified Ma Xing Shi Gan Decoction and 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 in people with Chronic Obstructive Pulmonary Disease, run by Cuiling Feng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuiling Feng (010-88325882, fengcuiling@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (days) (time frame: collected at baseline, 7 days, and 14 days post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.