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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Tract Diseases, Nose Diseases, Rhinitis

Intervention / Treatment
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* Drug: Hyeonggaeyeongyo-tang


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyeonggaeyeongyo-tang<br> | Drug: Hyeonggaeyeongyo-tang<br> <br> * Other names: Hyenggaelong Granule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 'Total nasal symptom score (TNSS)' |  | 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 |  | At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 2(Scheduled within a week of baseline) | 
| Change from baseline in 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)' |  | 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 | 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) | Day 2(Scheduled within a week of baseline) | 
| 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 | Day 2(Scheduled within a week of baseline) | 
| Change from baseline in total immunoglobulin E (IgE) |  | Day 2(Scheduled within a week of baseline), Week 5 | 
| Change from baseline in 'Heart Rate Variability' |  | Day 2(Scheduled within a week of baseline), Week 5 | 
| 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). | Day 2(Scheduled within a week of baseline), Week 5 | 
| Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P) |  | Day 2(Scheduled within a week of baseline) | 
| Change from baseline in 'Perceived Stress Scale' |  | Day 2(Scheduled within a week of baseline), Week 5 | 
| Change from baseline in eosinophil count level |  | Day 2(Scheduled within a week of baseline), Week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyeonggaeyeongyo-tang, Chronic rhinitis, Pattern identification, Korean medicine