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

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Allergic Asthma

Treatments: Drug: Budesonide and Formoterol Fumarate Powder for Inhalation; Drug: Placebo; Drug: Modified Shenling Baizhu Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT07352488

2024YFC3505302

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation.

Treatment:

Drug: Modified Shenling Baizhu Powder

Drug: Budesonide and Formoterol Fumarate Powder for Inhalation

Control group

Placebo Comparator group

Description:

The control group will receive a placebo in addition to Budesonide and Formoterol Fumarate Powder for Inhalation.

Treatment:

Drug: Budesonide and Formoterol Fumarate Powder for Inhalation

Drug: Placebo