NCT06691802

Clinical Study on the Treatment of Chronic Airway Diseases (Asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie

Clinical Study on Reducing Recurrent Attacks of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie Based on "winter Disease Being Cared in Summer"

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,312 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Conduct a multi-center, large-sample, randomized controlled clinical study of "winter disease being cared in summer" with Shu Fei Tie prevent recurrence of Asthma and COPD, scientifically evaluate the clinical efficacy and safety of Shu Fei Tie in reducing the recurrence of chronic airway diseases, identify target population, clarify the mechanism of efficacy, and establish a prevention and treatment technology plan for Shu Fei Tie to reduce the recurrence of chronic airway diseases.

Detailed description

Asthma and Chronic obstructive pulmonary disease (COPD) are the most common chronic airway diseases, and their recurrent episodes or acute exacerbations are the main reasons for the decline in patients' quality of life and heavy economic burden. Based on the of "winter disease being cared in summer", traditional Chinese medicine (TCM) has a long history and wide application in preventing and treating the recurrence of chronic air diseases, with obvious advantages of combining TCM and Western medicine. However, there is a lack of integrated TCM and Western medicine technical schemes for chronic airway based on high-level evidence-based evidence. The Shu Fei Tie developed by our project team is a medical institution preparation that has been used clinically for a long. Therefore, this study conducted a multi-center, large-sample, randomized controlled clinical study of the Shu Fei Tie to prevent the recurrence of asthma and COPD. The study subjects were patients in the remission period of asthma (1332 cases) and the stable period of COPD (980 cases) On the basis of treatment guided by the guidelines, the experimental group was given the Shu Fei Tie, and the control group was given a placebo of theu Fei Tie. The treatment started 10 days before the " the first Fu" and was conducted every 10 days, A total of 5 times, Each treatment lasted 6-8 hours, and the follow-up period was 45 weeks, for a total of 3 cycles (3 years). The outcome indicators were the number of acute attacks per year for asthma and the number of acute exacerbations per year for COPD. The secondary outcome indicators for asthma included Asthma Control Test (ACT) score, the Asthma Control Questionnaire (ACQ), and the Asthma Quality of Life Questionnaire (AQLQ). For COPD, the secondary outcome indicators included clinical symptom scores and lung function. This study scientifically evaluated the clinical efficacy and safety of the Shu Fei Tie reducing the recurrence of chronic airway diseases, identified the advantageous population, elucidated the mechanism of efficacy, and established a technical scheme for preventing and treating the recurrence of chronic airway diseases with the Shu Fei Tie.

Conditions

• Chronic Obstructive Pulmoriary Disease (COPD)
• Asthma

Interventions

Type	Name	Description
DRUG	Shu Fei Tie	Optimize the extraction process and matrix formulation, and combine the use of traditional Chinese medicine volatile oil and chemical transdermal enhancers to develop adermal patch（Shu Fei Tie）
DRUG	Shu Fei Tie placebo	Shu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-12-01
• Completion: 2028-07-01
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: China