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Efficacy Observation on Tian Jiu Therapy for Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tian Jiu Therapy
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- History of Asthma

Diagnostic Criteria of Asthma according to U.S.DHHS(2007):

  1. Episodic symptoms of airflow obstruction
  2. Difficulty breathing
  3. Chest tightness
  4. Cough (worse at night)
  5. Symptoms occurring or worsening at night, awakening the patient
  6. Symptoms occurring or worsening with exercise, viral infections, changes in weather, strong emotions, or mens; or in the presence of animals, dust mites, mold, smoke, pollen, or chemicals
  7. Wheezing
  8. Airflow obstruction at least partially reversible Medically stable and acute medical care does not require. E.g. intensive monitoring, invasive ventilation, haemoid-dialysis, cardiac support.

Exclusion Criteria:

  1. Patients currently experiencing Acute asthma attack
  2. Infants and child under thirteen years old 3.Pregnant women

4. Patients with

  1. Fever and pharyngitis
  2. Tuberculosis
  3. Severe cardiac and pulmonary diseases
  4. Diabetes Mellitus
  5. Hypersensitive skin condition
  6. Allergy to topical medication
  7. Keloid
  8. Bleeding disorders
  9. Severe heart diseases and with pacemaker.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Tian Jiu Therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    The change in Quality of life
    The change in Quality of life (SF-36 score)
    The change in the frequency of asthma attack
    The change in the frequency of asthma attack
    The change in admission to hospital
    The change in admission to hospital
    The change in AE visit
    The change in AE visit
    The change in clinic visit
    The change in clinic visit

    Secondary Outcome Measures

    The change of Pulmonary Function (FEV1)
    The change of Pulmonary Function (FEV1)
    The change of Pulmonary Function (FEV1/FEC)
    The change of Pulmonary Function (FEV1/FEC)

    Full Information

    First Posted
    February 27, 2019
    Last Updated
    November 1, 2022
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05093062
    Brief Title
    Efficacy Observation on Tian Jiu Therapy for Asthma
    Official Title
    Efficacy Observation on Tian Jiu Therapy for Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (Actual)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    August 31, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objectives: To further evaluate the immediate, long-term and cumulative effects of Tian Jiu Therapy on asthma. Hypothesis to be tested: The efficacy of Tian Jiu Therapy on asthma is also long-term and will be accumulated. Design and Subjects: Recruiting 167 asthma participants who received Tian Jiu Therapy under the primary study of HKCTR-1128. All subjects should be above age 13 and receive the same Tian Jiu Therapy, 3 times per year from 2013 to 2015. A one-year follow-up after the last Tian Jiu treatment will be conducted. Study instruments: Modern USB PC-based Spirometer and Fingertip Pulse Oximeter. Interventions: Plastering some stimulating Chinese herbal cubes on certain acupoints in the three hottest days of each year, for three consecutive years. Main outcome measures: Pulmonary Function Test, Blood Oxygen Test, Quality of Life and Standardized Questionnaire on asthma attack and symptoms will be administered before treatment, after treatment of each year and one-year follow-up after the last treatment. Data analysis: All the parameters will be analyzed, the physical improvement (Cured, Remarkably effective, Effective and Ineffective) will be recorded, and the differences in different treatment courses will be investigated and compared with previous data obtained in the primary study of HKCTR-1128 by using standard statistical analysis. Expected results: The effect of Tian Jiu Therapy on Asthma is not only immediate but also long-term and will be gradually accumulated. The Tian Jiu Therapy will acquire better efficacy on asthma if this treatment was conducted more years continuously.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Allocation
    N/A
    Enrollment
    136 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tian Jiu Therapy
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Tian Jiu Therapy
    Primary Outcome Measure Information:
    Title
    The change in Quality of life
    Description
    The change in Quality of life (SF-36 score)
    Time Frame
    baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
    Title
    The change in the frequency of asthma attack
    Description
    The change in the frequency of asthma attack
    Time Frame
    baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
    Title
    The change in admission to hospital
    Description
    The change in admission to hospital
    Time Frame
    baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
    Title
    The change in AE visit
    Description
    The change in AE visit
    Time Frame
    baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
    Title
    The change in clinic visit
    Description
    The change in clinic visit
    Time Frame
    baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
    Secondary Outcome Measure Information:
    Title
    The change of Pulmonary Function (FEV1)
    Description
    The change of Pulmonary Function (FEV1)
    Time Frame
    baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
    Title
    The change of Pulmonary Function (FEV1/FEC)
    Description
    The change of Pulmonary Function (FEV1/FEC)
    Time Frame
    baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - History of Asthma Diagnostic Criteria of Asthma according to U.S.DHHS(2007): Episodic symptoms of airflow obstruction Difficulty breathing Chest tightness Cough (worse at night) Symptoms occurring or worsening at night, awakening the patient Symptoms occurring or worsening with exercise, viral infections, changes in weather, strong emotions, or mens; or in the presence of animals, dust mites, mold, smoke, pollen, or chemicals Wheezing Airflow obstruction at least partially reversible Medically stable and acute medical care does not require. E.g. intensive monitoring, invasive ventilation, haemoid-dialysis, cardiac support. Exclusion Criteria: Patients currently experiencing Acute asthma attack Infants and child under thirteen years old 3.Pregnant women 4. Patients with Fever and pharyngitis Tuberculosis Severe cardiac and pulmonary diseases Diabetes Mellitus Hypersensitive skin condition Allergy to topical medication Keloid Bleeding disorders Severe heart diseases and with pacemaker.

    12. IPD Sharing Statement

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    Efficacy Observation on Tian Jiu Therapy for Asthma

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