Allergic AsthmamSLBZP-AsthmaNCT07352488
Modified Shenling Baizhu Powder for Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome
A study testing Modified Shenling Baizhu Powder and Budesonide and Formoterol Fumarate Powder for Inhalation in people with Allergic Asthma, run by Henan University of Traditional Chinese Medicine at 3 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Modified Shenling Baizhu Powder and Budesonide and Formoterol Fumarate Powder for Inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jan 2026to 31 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450003
About this study
Official title: 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.
- Conditions
- Allergic Asthma
- Being tested
- Modified Shenling Baizhu Powder, Placebo, Budesonide and Formoterol Fumarate Powder for Inhalation
- Keywords
- Allergic asthma, Modified Shenling Baizhu Powder, Spleen Deficiency and Dampness Accumulation Syndrome, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Shenling Baizhu PowderDrug
Modified Shenling Baizhu Powder will be taken twice daily.
PlaceboDrug
The placebo will be taken twice daily.
Budesonide and Formoterol Fumarate Powder for InhalationDrug
Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation. Receives: Drug: Modified Shenling Baizhu Powder; Drug: Budesonide and Formoterol Fumarate Powder for Inhalation |
| Control group | Placebo comparator | The control group will receive a placebo in addition to Budesonide and Formoterol Fumarate Powder for Inhalation. Receives: Drug: Placebo; Drug: Budesonide and Formoterol Fumarate Powder for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test scores
To be measured by Asthma Control Test.
Measured: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Secondary outcomes (9)
Acute exacerbation
To be measured by the frequency and severity of acute exacerbation, and the time to first acute exacerbation.
Measured: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Asthma Control Questionnaire scores
To be measured by Asthma Control Questionnaire.
Measured: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Asthma Quality of Life Questionnaire scores
To be measured by Asthma Quality of Life Questionnaire.
Measured: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Pulmonary function
To be measured by pulmonary function test.
Measured: At baseline, week 8 of treatment, and week 12 of follow-up.
Airway inflammatory markers
To be measured by fractional exhaled nitric oxide.
Measured: At baseline, week 8 of treatment, and week 12 of follow-up.
Clinical symptom scores
To be measured by clinical symptom questionnaire.
Measured: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Serum inflammatory markers
To be measured by blood eosinophil count, total serum IgE, IL-4, IL-5, TNF-α, etc.
Measured: At baseline, week 4 and week 8 of treatment.
Immune markers
To be measured by CD4+, CD8+, CD4+/CD8+, Th17, and Treg.
Measured: At baseline, week 4 or week 8 of treatment.
Use of controller medications
To be measured by the usage of bronchodilator and glucocorticoid.
Measured: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352488
- Sponsor's protocol ID
- 2024YFC3505302
- Acronym
- mSLBZP-Asthma
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Shenling Baizhu Powder on Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07352488
- Acronym / sponsor ID
- mSLBZP-Asthma / 2024YFC3505302
- Conditions
- Allergic Asthma
- Keywords
- Allergic asthma, Modified Shenling Baizhu Powder, Spleen Deficiency and Dampness Accumulation Syndrome, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Modified Shenling Baizhu Powder, Drug: Budesonide and Formoterol Fumarate Powder for InhalationThe experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation. |
| Control group | Placebo comparator | Drug: Placebo, Drug: Budesonide and Formoterol Fumarate Powder for InhalationThe control group will receive a placebo in addition to Budesonide and Formoterol Fumarate Powder for Inhalation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 Shenling Baizhu PowderModified Shenling Baizhu Powder will be taken twice daily. | Drug | Experimental group |
| PlaceboThe placebo will be taken twice daily. | Drug | Control group |
| Budesonide and Formoterol Fumarate Powder for InhalationBudesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily. | Drug | Control group, Experimental group |
Primary outcome
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.
9 secondary outcomes
Acute exacerbation
Time frame: 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.
Asthma Quality of Life Questionnaire scores
Time frame: 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.
Airway inflammatory markers
Time frame: 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.
Serum inflammatory markers
Time frame: At baseline, week 4 and week 8 of treatment.
Immune markers
Time frame: 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.
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 20 Jan 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Shenling Baizhu Powder and Budesonide and Formoterol Fumarate Powder for Inhalation in people with Allergic Asthma, run by Henan University of Traditional Chinese Medicine at 3 sites in China.
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 4 inclusion and 8 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jiajia Wang, M.D. (+86-371-66248624, wangiahn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test scores (time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.). 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 20 Jan 2026.