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

Not Yet RecruitingNA

Sponsor: Henan University of Traditional Chinese Medicine

Conditions: Allergic Asthma

Interventions: Modified Shenling Baizhu Powder, Placebo, Budesonide and Formoterol Fumarate Powder for Inhalation

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (3)

Zhengzhou, Henan, China
Jinan, Shandong, China
Hangzhou, Zhejiang, China