NCT01293734

Brief Summary

Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
Last Updated

February 11, 2011

Status Verified

January 1, 2011

Enrollment Period

2.1 years

First QC Date

February 10, 2011

Last Update Submit

February 10, 2011

Conditions

Bronchial Asthma

Keywords

bronchial asthmacold typeheat typeAsthenia typeTCM syndromesymptomsphysical signs

Outcome Measures

Primary Outcomes (3)

  • primary Symptom

    Symptom: wheezing, cough, choking

    30 days

  • physical sign

    physical sign: wheezing sound

    30 days

  • assistant examination

    Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC

    30 days

Secondary Outcomes (2)

  • Secondary Symptom

    30 days

  • physical sign

    30 days

Study Arms (4)

cold type

EXPERIMENTAL

To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type

Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum

heat type

EXPERIMENTAL

To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.

Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum

Asthenia type

EXPERIMENTAL

To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.

Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum

Western medicine control group

ACTIVE COMPARATOR
Drug: Theophylline Sustained-release Tablets and budesonide suspension

Interventions

warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrumOTHER

warming lung and relieving asthmatic granule:once 1 bag, 3 times a day. Securing origin and warming lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day

cold type
clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrumOTHER

clearing lung and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and clearing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day

heat type
securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrumOTHER

securing origin and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and nourishing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day

Asthenia type
Theophylline Sustained-release Tablets and budesonide suspensionDRUG

Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day

Western medicine control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 65 years old;
  • Patients with mild-to-moderate bronchial asthma on attacking stage;
  • Without cardiopulmonary or other complications;
  • To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;
  • Informed consent form is required to be signed.

You may not qualify if:

  • Older than 65 years or younger than 18 years old;
  • Pregnant woman or suckling period woman;
  • Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.
  • Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;
  • Irritable the physique, or allergic to the given composition of drugs in this research;
  • Patients who are in the process of other clinical research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

December 1, 2008

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

February 11, 2011

Record last verified: 2011-01