Clinical Study on Treatment of Chronic Persistent Bronchial Asthma

NCT ID: NCT03228134

Last Updated: 2023-05-25

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-09-30

Brief Summary

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Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.

Detailed Description

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The incidence of asthma in China is high and the rate of control is low. Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.

In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.

Conditions

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Bronchial Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Double-blind trial

Study Groups

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Hanxiao treatment group

80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.

Group Type EXPERIMENTAL

Ke Chuan Liu Wei Granule

Intervention Type DRUG

Traditional Chinese Medicine

Hanxiao control group

80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.

Group Type SHAM_COMPARATOR

Ke Chuan Liu Wei Granule placebo

Intervention Type OTHER

Placebo

Xuxiao treatment group

80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.

Group Type EXPERIMENTAL

Yang He Ping Chuan Granule

Intervention Type DRUG

Traditional Chinese Medicine

Xuxiao control group

80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.

Group Type SHAM_COMPARATOR

Yang He Ping Chuan Granule placebo

Intervention Type OTHER

Placebo

Interventions

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Ke Chuan Liu Wei Granule

Traditional Chinese Medicine

Intervention Type DRUG

Yang He Ping Chuan Granule

Traditional Chinese Medicine

Intervention Type DRUG

Ke Chuan Liu Wei Granule placebo

Placebo

Intervention Type OTHER

Yang He Ping Chuan Granule placebo

Placebo

Intervention Type OTHER

Other Intervention Names

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KCLW Granule YHPC Granule Placebo Placebo

Eligibility Criteria

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Inclusion Criteria

* Patient diagnosed with chronic persistent asthma
* Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
* Conform to the predetermined 2 TCM Syndrome Types
* Patients who have given written informed consent

Exclusion Criteria

* Smoking and continuous exposure to hazardous environment
* With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
* Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
* Patients who are allergic to therapeutic medicine
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Longhua Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huiyong Zhang, Director

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Fenglin Street Community Health Service Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Kangjian Street Community Health Service Center

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Tianping Street Community Health Service Center

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Longhua Hospital Affiliated Shanghai University of TCM

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Fengxian District Hospital of TCM

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zifeng Ma, Doctor

Role: CONTACT

+8621-64385700 ext. 1307

Zhenghui Lu, PHD

Role: CONTACT

+8621-64385700 ext. 1307

Facility Contacts

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Chuntao Yi, Master

Role: primary

+8618817338803

Taiquan Huang, Master

Role: primary

+8613918375404

Xin He, Master

Role: primary

+8613501903509

Zifeng Ma, Master

Role: primary

+8618817338863

Fang Fang, Master

Role: primary

+8613816856217

Other Identifiers

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2017LCSY347

Identifier Type: -

Identifier Source: org_study_id

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