search
Back to results

The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine

Primary Purpose

Respiratory Tract Diseases, Nose Diseases, Rhinitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hyeonggaeyeongyo-tang
Sponsored by
Kyung Hee University Hospital at Gangdong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Diseases focused on measuring Hyeonggaeyeongyo-tang, Chronic rhinitis, Pattern identification, Korean medicine

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who are diagnosed by moderate level of chronic rhinitis for more than 8 weeks

    • At least one of the following conditions: Nasal congestion, rhinorrhea, sneeze, pruritus
    • At least one of the following Moderate abnormality conditions: sleep disturbance; daily activity, physical exercise, leisure activity limitations; work/school work limitations; discomfort with several symptoms
  2. Age between 19 and 65 years
  3. Able to dialogue
  4. Agree with informed consent

Exclusion Criteria:

  1. Patients who are taken one of the following drugs for treating rhinitis or acute upper respiratory infections etc

    • Drugs which determined to have negative effect on symptoms of rhinitis or skin prick test (oral or nasal)

      • Short acting anti-histamines / H1 blockers (drug use within lase 1 week)

        • Long acting anti-histamines / H1 blockers (drug use within lase 2 week)

          • Corticosteroids (drug use within lase 1 month) ④ Anti-cholinergic drug (drug use within lase 1 week)

            • Anti-leukotriene drug (drug use within lase 1 week)

              • Decongestants (drug use within lase 1 week) ⑦ Tricyclic antidepressants, phenothiazines (drug use within lase 2 week) ⑧ Non-steroidal analgesics (drug use within lase 1 week) ⑨ Drugs that is judged to be inappropriate for the trial by the researchers
  2. Used Korean medicine for treating rhinitis within last 7 days
  3. Patients who has severe disease, such as malignant tumor, severe dyslipidemia, liver or kidney dysfunction, anemia, active pulmonary tuberculosis, infection or systemic disease etc
  4. Presence of internal nasal obstruction or nasal deformities or history of nasal surgery within 2 months
  5. History of active respiratory disease(ex. asthma)
  6. Hypertension or Diabetes
  7. Experienced immunotherapy or systemic steroid treatments within last 3 months
  8. Experienced drug allergic reactions
  9. Experienced anaphylactic reactions, during allergen test
  10. Female patients who are pregnant or lactating or have the chances of pregnancy
  11. Patients who are participated other clinical trials within last 1 month
  12. Patients who are unable to participate the trial (paralysis, severe mental or psychological illness, dementia, drug addiction, unable to make to participate in the trial, severe visual or auditory dysfunction, unable to visit hospital regularly, unable to communicate through spoken or written Korean etc)
  13. Patients who are judged to be inappropriate for the clinical study by the researchers

Sites / Locations

  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyeonggaeyeongyo-tang

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in 'Total nasal symptom score (TNSS)'
Change from baseline in 'pre KiFDA-AR ver 2.0' Questionnaire

Secondary Outcome Measures

Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'
Pattern Diagnosis(either cold or heat pattern) based on the results of Cold-heat Pattern Identification Questionnaire
Change from baseline in 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)'
Pattern diagnosis by doctor of Korean medicine by traditional Korean medicine doctor's four examination
Pattern Diagnosis(either wind-heat or wind-cold pattern) based on the results of traditional Korean medicine doctor's four examination(questioning/history taking, inspection, auscultation (listening) & olfaction (smelling), and palpation)
Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test
Observed the allergic reaction for assessing the allergenicity of patients with allergic rhinitis
Change from baseline in total immunoglobulin E (IgE)
Change from baseline in 'Heart Rate Variability'
Change from Baseline in 'Ryodoraku values'
Investigate the different changes on autonomic nervous system from Ryodoraku value. The 12 measured Ryodoraku points are 6 on the hand(represented as H) and 6 on the feet(represented as F).
Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P)
Change from baseline in 'Perceived Stress Scale'
Change from baseline in eosinophil count level

Full Information

First Posted
June 10, 2015
Last Updated
December 28, 2016
Sponsor
Kyung Hee University Hospital at Gangdong
search

1. Study Identification

Unique Protocol Identification Number
NCT02477293
Brief Title
The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine
Official Title
The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Hyeonggaeyeongyo-Tang for chronic rhinitis according to pattern identification in Korean medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Diseases, Nose Diseases, Rhinitis
Keywords
Hyeonggaeyeongyo-tang, Chronic rhinitis, Pattern identification, Korean medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyeonggaeyeongyo-tang
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hyeonggaeyeongyo-tang
Other Intervention Name(s)
Hyenggaelong Granule
Primary Outcome Measure Information:
Title
Change from baseline in 'Total nasal symptom score (TNSS)'
Time Frame
At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
Title
Change from baseline in 'pre KiFDA-AR ver 2.0' Questionnaire
Time Frame
At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
Secondary Outcome Measure Information:
Title
Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'
Description
Pattern Diagnosis(either cold or heat pattern) based on the results of Cold-heat Pattern Identification Questionnaire
Time Frame
Day 2(Scheduled within a week of baseline)
Title
Change from baseline in 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)'
Time Frame
At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
Title
Pattern diagnosis by doctor of Korean medicine by traditional Korean medicine doctor's four examination
Description
Pattern Diagnosis(either wind-heat or wind-cold pattern) based on the results of traditional Korean medicine doctor's four examination(questioning/history taking, inspection, auscultation (listening) & olfaction (smelling), and palpation)
Time Frame
Day 2(Scheduled within a week of baseline)
Title
Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test
Description
Observed the allergic reaction for assessing the allergenicity of patients with allergic rhinitis
Time Frame
Day 2(Scheduled within a week of baseline)
Title
Change from baseline in total immunoglobulin E (IgE)
Time Frame
Day 2(Scheduled within a week of baseline), Week 5
Title
Change from baseline in 'Heart Rate Variability'
Time Frame
Day 2(Scheduled within a week of baseline), Week 5
Title
Change from Baseline in 'Ryodoraku values'
Description
Investigate the different changes on autonomic nervous system from Ryodoraku value. The 12 measured Ryodoraku points are 6 on the hand(represented as H) and 6 on the feet(represented as F).
Time Frame
Day 2(Scheduled within a week of baseline), Week 5
Title
Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P)
Time Frame
Day 2(Scheduled within a week of baseline)
Title
Change from baseline in 'Perceived Stress Scale'
Time Frame
Day 2(Scheduled within a week of baseline), Week 5
Title
Change from baseline in eosinophil count level
Time Frame
Day 2(Scheduled within a week of baseline), Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are diagnosed by moderate level of chronic rhinitis for more than 8 weeks At least one of the following conditions: Nasal congestion, rhinorrhea, sneeze, pruritus At least one of the following Moderate abnormality conditions: sleep disturbance; daily activity, physical exercise, leisure activity limitations; work/school work limitations; discomfort with several symptoms Age between 19 and 65 years Able to dialogue Agree with informed consent Exclusion Criteria: Patients who are taken one of the following drugs for treating rhinitis or acute upper respiratory infections etc Drugs which determined to have negative effect on symptoms of rhinitis or skin prick test (oral or nasal) Short acting anti-histamines / H1 blockers (drug use within lase 1 week) Long acting anti-histamines / H1 blockers (drug use within lase 2 week) Corticosteroids (drug use within lase 1 month) ④ Anti-cholinergic drug (drug use within lase 1 week) Anti-leukotriene drug (drug use within lase 1 week) Decongestants (drug use within lase 1 week) ⑦ Tricyclic antidepressants, phenothiazines (drug use within lase 2 week) ⑧ Non-steroidal analgesics (drug use within lase 1 week) ⑨ Drugs that is judged to be inappropriate for the trial by the researchers Used Korean medicine for treating rhinitis within last 7 days Patients who has severe disease, such as malignant tumor, severe dyslipidemia, liver or kidney dysfunction, anemia, active pulmonary tuberculosis, infection or systemic disease etc Presence of internal nasal obstruction or nasal deformities or history of nasal surgery within 2 months History of active respiratory disease(ex. asthma) Hypertension or Diabetes Experienced immunotherapy or systemic steroid treatments within last 3 months Experienced drug allergic reactions Experienced anaphylactic reactions, during allergen test Female patients who are pregnant or lactating or have the chances of pregnancy Patients who are participated other clinical trials within last 1 month Patients who are unable to participate the trial (paralysis, severe mental or psychological illness, dementia, drug addiction, unable to make to participate in the trial, severe visual or auditory dysfunction, unable to visit hospital regularly, unable to communicate through spoken or written Korean etc) Patients who are judged to be inappropriate for the clinical study by the researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Kyu Ko, KMD, PhD
Organizational Affiliation
Kyunghee University
Official's Role
Study Chair
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27698676
Citation
Kim MH, Son J, Nam HJ, Ko SG, Choi I. Hyeonggaeyeongyo-Tang for Treatment of Allergic and Nonallergic Rhinitis: A Prospective, Nonrandomized, Pre-Post Study. Evid Based Complement Alternat Med. 2016;2016:9202675. doi: 10.1155/2016/9202675. Epub 2016 Sep 6.
Results Reference
result

Learn more about this trial

The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine

We'll reach out to this number within 24 hrs