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Clinical Evidence-Based Evaluation Study of Yanghe Dingchuan Ointment for the Treatment of Late-Onset Asthma in the Elderly (LOA)

Clinical Evidence-Based Evaluation Study of Yanghe Dingchuan Ointment for the Treatment of Late-Onset Asthma in the Elderly (LOA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001796
Enrollment
Unknown
Registered
2025-09-21
Start date
2025-10-07
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-Onset Asthma in the Elderly

Interventions

control group:Symbicort Turbuhaler (160µg/4.5µg) + Yanghe Dingchuan Ointment placebo (oral 45g each time twice daily),continuous intervention for 4 weeks
treatment group:Symbicort Turbuhaler (160µg/4.5µg) +Yanghe Dingchuan Ointment (oral 45g each time twice daily)continuous intervention for 4 weeks

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Disease severity is in the LOA remission phase; 2. Meets the diagnostic criteria for traditional Chinese medicine deficiency asthma (lung and kidney qi deficiency syndrome); 3. Age between 60 and 75 years old, no gender restrictions; 4. Willing to undergo standardized integrated traditional Chinese and Western medicine treatment; 5. Agrees to sign an informed consent form; 6. Able to undergo pulmonary function tests/bronchodilator tests according to ATS (American Thoracic Society) standards.

Exclusion criteria

Exclusion criteria: 1. Diseases with known etiology or specific pathological manifestations and airflow obstruction, such as cystic fibrosis, diffuse panbronchiolitis, or obstructive bronchiolitis, as well as other pulmonary diseases such as tuberculosis or malignant tumors of the lung; 2. History of immunodeficiency disorders, including HIV-positive status, other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 3. History of bleeding disorders; 4. Concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or may interfere with the patient's ability to complete the study (e.g., severe arrhythmias, significantly reduced creatinine clearance, severe hypertension, diabetes, etc.); 5. Concurrent use of any other asthma/COPD treatment outside the study protocol (ICS+LABA, SABA), such as biologics like omalizumab; 6. Pregnant or breastfeeding women; 7. History of alcohol abuse or other harmful habits; Alcohol abuse refers to drinking four or more times within approximately two hours, with one drink defined as 150 mL of wine, 350 mL of beer, or 50 mL of 50% alcohol; 8. Patients who cannot comply with the trial protocol or are unable to understand the nature, scope, and consequences of this study; 9. Patients with a known history of allergy to any component of this medication.

Design outcomes

Primary

MeasureTime frame
Asthma Control Test Score;

Secondary

MeasureTime frame
Percentage of forced expiratory volume in one second (FEV1) to predicted value;Traditional Chinese Medicine Syndrome Scoring;Number of acute asthma exacerbations;Hospitalization rates for acute exacerbations of asthma;Peak expiratory flow (PEF) variation curve;Forced expiratory volume in one second/forced vital capacity;Fractional exhaled nitric oxide;

Countries

China

Contacts

Public ContactCui Jie

Longhua Hospital Shanghai University of Traditional Chinese Medicine

cuij1998@163.com18317089157

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026