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

NCT07352488 | Not Yet Recruiting DMC

• 1 other identifier: 2024YFC3505302
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Allergic Asthma

Keywords

Allergic asthma; Modified Shenling Baizhu Powder; Spleen Deficiency and Dampness Accumulation Syndrome; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test scores

  To be measured by Asthma Control Test.

  At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.

Secondary Outcomes (9)

• Acute exacerbation

  At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.

• Asthma Control Questionnaire scores

  At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.

• Asthma Quality of Life Questionnaire scores

  At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.

• Pulmonary function

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

• Airway inflammatory markers

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

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

Control group

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Budesonide and Formoterol Fumarate Powder for Inhalation

Interventions

Modified Shenling Baizhu Powder DRUG

Modified Shenling Baizhu Powder will be taken twice daily.

Experimental group

Placebo DRUG

The placebo will be taken twice daily.

Control group

Budesonide and Formoterol Fumarate Powder for Inhalation DRUG

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

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (3)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450003, China

Location

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250011, China

Location

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

Budesonide; Inhalation

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Jiajia Wang, M.D.

CONTACT

+86-371-66248624; wangiahn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)