Modified Shenling Baizhu Powder for Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome (mSLBZP-Asthma)

January 11, 2026 updated by: Henan University of Traditional Chinese Medicine

Effect of Modified Shenling Baizhu Powder on Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome: A Multicenter, Randomized Controlled Trial

Allergic asthma is a common allergic disease characterized by a protracted disease course and recurrent episodes, which severely impairs patients' physical and mental health. There is a paucity of high-quality clinical evidence in the treatment of allergic asthma with traditional Chinese medicine (TCM). This study will enroll patients who are persistent allergic asthma with spleen deficiency and dampness accumulation syndrome. A multicenter, randomized, double-blind, placebo-controlled trial design is adopted. The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation, while the control group will receive a placebo in addition to the same inhalation therapy. Both groups will undergo an 8 week of treatment followed by a 12 week of follow-up. The primary outcome is Asthma Control Test scores, and the secondary outcomes include acute exacerbations, Asthma Control Questionnaire scores, Asthma Quality of Life Questionnaire scores, pulmonary function, airway inflammatory markers, clinical symptom scores, serum inflammatory markers, immune markers, and use of controller medications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jiajia Wang, M.D.
  • Phone Number: +86-371-66248624
  • Email: wangiahn@163.com

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450003
        • The First Affiliated Hospital of Henan University of Chinese Medicine
    • Shandong
      • Jinan, Shandong, China, 250011
        • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Hangzhou Third People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are persistent allergic asthma.
  • Patients who meet the diagnostic criteria for the spleen deficiency and dampness accumulation syndrome.
  • Patients who are aged between 18 and 80 years.
  • Patients who voluntarily accept the treatment and sign the informed consent form.

Exclusion Criteria:

  • Patients who have chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis , active pulmonary tuberculosis, or pulmonary embolism, etc.
  • Patients who have severe cardiovascular or cerebrovascular diseases.
  • Patients who have severe liver or kidney diseases.
  • Patients who have a history of tumor.
  • Patients who have cognitive impairment or psychiatric disorders.
  • Patients who are pregnant or breastfeeding.
  • Patients who are allergic to medication(s) used.
  • Patients who participated in another clinical trial within one month prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation.
Drug: Modified Shenling Baizhu Powder
Modified Shenling Baizhu Powder will be taken twice daily.
Drug: Budesonide and Formoterol Fumarate Powder for Inhalation
Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.
Placebo Comparator: Control group
The control group will receive a placebo in addition to Budesonide and Formoterol Fumarate Powder for Inhalation.
Drug: Budesonide and Formoterol Fumarate Powder for Inhalation
Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.
Drug: Placebo
The placebo will be taken twice daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Asthma Control Test scores
Time Frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
To be measured by Asthma Control Test.
At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute exacerbation
Time Frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
To be measured by the frequency and severity of acute exacerbation, and the time to first acute exacerbation.
At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Asthma Control Questionnaire scores
Time Frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
To be measured by Asthma Control Questionnaire.
At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Asthma Quality of Life Questionnaire scores
Time Frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
To be measured by Asthma Quality of Life Questionnaire.
At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Pulmonary function
Time Frame: At baseline, week 8 of treatment, and week 12 of follow-up.
To be measured by pulmonary function test.
At baseline, week 8 of treatment, and week 12 of follow-up.
Airway inflammatory markers
Time Frame: At baseline, week 8 of treatment, and week 12 of follow-up.
To be measured by fractional exhaled nitric oxide.
At baseline, week 8 of treatment, and week 12 of follow-up.
Clinical symptom scores
Time Frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
To be measured by clinical symptom questionnaire.
At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Serum inflammatory markers
Time Frame: At baseline, week 4 and week 8 of treatment.
To be measured by blood eosinophil count, total serum IgE, IL-4, IL-5, TNF-α, etc.
At baseline, week 4 and week 8 of treatment.
Immune markers
Time Frame: At baseline, week 4 or week 8 of treatment.
To be measured by CD4+, CD8+, CD4+/CD8+, Th17, and Treg.
At baseline, week 4 or week 8 of treatment.
Use of controller medications
Time Frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
To be measured by the usage of bronchodilator and glucocorticoid.
At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024YFC3505302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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