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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minhee Kim, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier:
NCT02477293
First received: June 10, 2015
Last updated: December 28, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Respiratory Tract Diseases
Nose Diseases
Rhinitis
Drug: Hyeonggaeyeongyo-tang
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine

Further study details as provided by Kyung Hee University Hospital at Gangdong:

Primary Outcome Measures:
  • 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 ]
  • 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 Measures:
  • Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire' [ Time Frame: Day 2(Scheduled within a week of baseline) ]
    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)' [ Time Frame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13 ]
  • Pattern diagnosis by doctor of Korean medicine by traditional Korean medicine doctor's four examination [ Time Frame: Day 2(Scheduled within a week of baseline) ]
    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 [ Time Frame: Day 2(Scheduled within a week of baseline) ]
    Observed the allergic reaction for assessing the allergenicity of patients with allergic rhinitis

  • Change from baseline in total immunoglobulin E (IgE) [ Time Frame: Day 2(Scheduled within a week of baseline), Week 5 ]
  • Change from baseline in 'Heart Rate Variability' [ Time Frame: Day 2(Scheduled within a week of baseline), Week 5 ]
  • Change from Baseline in 'Ryodoraku values' [ Time Frame: Day 2(Scheduled within a week of baseline), Week 5 ]
    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) [ Time Frame: Day 2(Scheduled within a week of baseline) ]
  • Change from baseline in 'Perceived Stress Scale' [ Time Frame: Day 2(Scheduled within a week of baseline), Week 5 ]
  • Change from baseline in eosinophil count level [ Time Frame: Day 2(Scheduled within a week of baseline), Week 5 ]

Enrollment: 40
Study Start Date: August 2015
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyeonggaeyeongyo-tang Drug: Hyeonggaeyeongyo-tang
Other Name: Hyenggaelong Granule

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02477293

Locations
Korea, Republic of
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 05278
Sponsors and Collaborators
Kyung Hee University Hospital at Gangdong
Investigators
Study Chair: Seong-Kyu Ko, KMD, PhD Kyunghee University
  More Information

Publications:
Responsible Party: Minhee Kim, KMD, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier: NCT02477293     History of Changes
Other Study ID Numbers: B120014
Study First Received: June 10, 2015
Last Updated: December 28, 2016

Keywords provided by Kyung Hee University Hospital at Gangdong:
Hyeonggaeyeongyo-tang
Chronic rhinitis
Pattern identification
Korean medicine

Additional relevant MeSH terms:
Rhinitis
Respiratory Tract Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2017