NCT07352488Not yet recruiting
Modified Shenling Baizhu Powder for Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome
Effect of Modified Shenling Baizhu Powder on Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome: A Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 11 Jan 2026
- Start date
- 15 Jan 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Diseases
- Asthma
- NCT number
- NCT07352488
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 15 Jan 2026 to the primary completion date, 30 Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who participated in another clinical trial within one month prior to enrollment.
Other illness
- 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 allergic to medication(s) used.
Other
- Patients who are pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hangzhou Third People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Henan University of Chinese Medicine Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.