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

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: Not yet recruiting
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: Modified Shenling Baizhu Powder; Drug: Budesonide and Formoterol Fumarate Powder for Inhalation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Asthma Control Test scores	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

Outcome Measure	Measure Description	Time Frame
Acute exacerbation	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	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	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	To be measured by pulmonary function test.	At baseline, week 8 of treatment, and week 12 of follow-up.
Airway inflammatory markers	To be measured by fractional exhaled nitric oxide.	At baseline, week 8 of treatment, and week 12 of follow-up.
Clinical symptom scores	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	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	To be measured by CD4+, CD8+, CD4+/CD8+, Th17, and Treg.	At baseline, week 4 or week 8 of treatment.
Use of controller medications	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

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: January 11, 2026
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Allergic asthma; Modified Shenling Baizhu Powder; Spleen Deficiency and Dampness Accumulation Syndrome
• Additional Relevant MeSH Terms: Circulatory and Respiratory Physiological Phenomena; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Pregnenediones; Pregnenes; Budesonide; Inhalation
• Other Study ID 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