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NCT Number: NCT07352488

Modified Shenling Baizhu Powder for Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome

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.

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Key information

Conditions

Allergic Asthma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Shenling Baizhu Powder

Drug

Modified Shenling Baizhu Powder will be taken twice daily.

Placebo

Drug

The placebo will be taken twice daily.

Budesonide and Formoterol Fumarate Powder for Inhalation

Drug

Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Pulmonary function

    Time frame: At baseline, week 8 of treatment, and week 12 of follow-up.

    To be measured by pulmonary function test.

  5. 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.

  6. 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.

  7. 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.

  8. Immune markers

    Time frame: At baseline, week 4 or week 8 of treatment.

    To be measured by CD4+, CD8+, CD4+/CD8+, Th17, and Treg.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Wang, M.D.

CONTACT

[email protected]

+86-371-66248624

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Acronym: mSLBZP-Asthma

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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