Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine

NCT ID: NCT05459805

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To explore the disease outcome prognosis of cough variant asthma by observing the outcomes of cough variant asthma and the effects of Chinese and Western medicine interventions, and to provide a scientific basis for optimizing the treatment protocol of combined traditional and Western medicine for cough variant asthma. This is a multi-center, non-randomized, prospective cohort study. This study started in March 2022 and is going on now. On an informed consent basis, a cohort of 164 patients with diagnosis of CVA are engaged. All patients will receive 8-week treatment (ICS/LABA plus Chinese herbal medicine for trial group while ICS/LABA only for control group) and be observed in next 24 weeks. Patients will be followed up every 2 weeks during treatment period and every 4 weeks in observation.The feasibility and correctness of the study will be supervised by two supervisors. To ensure that participants adhere to their follow-up plans, we remind them of their fixed visiting by phone or message. Additionally, incentives are used to appreciate participants for their cooperation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cough Variant Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

those receive ICS/LABA plus traditional Chinese medicine

Group Type EXPERIMENTAL

traditional chinese medicine Xuanfei-Zhike formula

Intervention Type DRUG

200ml, bid, for 8 weeks

inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)

Intervention Type DRUG

one suction, q12h, for 8 weeks

group 2

those receive ICS/LABA alone

Group Type ACTIVE_COMPARATOR

inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)

Intervention Type DRUG

one suction, q12h, for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

traditional chinese medicine Xuanfei-Zhike formula

200ml, bid, for 8 weeks

Intervention Type DRUG

inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)

one suction, q12h, for 8 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. conform to diagnosis of CVA;
2. 18 years≤age≤65 years;
3. agree to participant in this trial.

Exclusion Criteria

1. comorbidity of respiratory and pulmonary infections;
2. history of mental illness;
3. comorbidity of heart and cardiovascular, liver, kidney and hematopoietic function and other severe diseases;
4. participants of other clinical trials who may make a difference in our trial;
5. treatment with other Chinese herb.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xin Hua Hospital of Zhejiang Province

OTHER

Sponsor Role collaborator

Hangzhou Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Affiliated Wenling Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Junchao Yang

Role: STUDY_CHAIR

The First Affiliated Hospital of Zhejiang Chinese Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, , China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, , China

Site Status RECRUITING

Xin Hua Hospital of Zhejiang Province

Hangzhou, , China

Site Status NOT_YET_RECRUITING

The First People's Hospital of Wenling

Taizhou, , China

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Junchao Yang

Role: CONTACT

+86 13858036093

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jingjing Hu

Role: primary

+86 15088648189

Junchao Yang

Role: primary

+86 13858036093

Minjing Li

Role: primary

+86 13588420329

Junfeng Chen

Role: primary

+86 15058600178

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ChiCTR2100048636

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022ZZ011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of MG-K10 in Subjects With Asthma
NCT05382910 UNKNOWN PHASE1/PHASE2