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Not yet recruiting NCT07352488

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

No phase Interventional Allergic Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified Shenling Baizhu Powder, Placebo, Budesonide and Formoterol Fumarate Powder for Inhalation.
Who it may be relevant to
Registry conditions: Allergic Asthma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Modified Shenling Baizhu Powder
    Modified Shenling Baizhu Powder will be taken twice daily.
  • Drug Placebo
    The placebo 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.

Primary outcome measures

  • Asthma Control Test scores [Time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.]
Secondary outcome measures (9)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 3 centers
  • The First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan
  • Hangzhou Third People's Hospital — Hangzhou

Identifiers

NCT: NCT07352488 · 2024YFC3505302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗