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

Kyung Hee University Hospital at Gangdong1 site in 1 country40 target enrollmentAugust 2015

ConditionsRespiratory Tract Diseases Nose Diseases Rhinitis

InterventionsHyeonggaeyeongyo-tang

DrugsHyeonggaeyeongyo-tang

Overview

Phase: Phase 4
Intervention: Hyeonggaeyeongyo-tang
Conditions: Respiratory Tract Diseases
Sponsor: Kyung Hee University Hospital at Gangdong
Enrollment: 40
Locations: 1
Primary Endpoint: Change from baseline in 'Total nasal symptom score (TNSS)'
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kyung Hee University Hospital at Gangdong

Responsible Party

Principal Investigator

Minhee Kim

KMD

Kyung Hee University Hospital at Gangdong

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

Arms & Interventions

Hyeonggaeyeongyo-tang

Intervention: Hyeonggaeyeongyo-tang

Outcomes

Primary Outcomes

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 Outcomes

Pattern Diagnosis by '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(Day 2(Scheduled within a week of baseline))
Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test(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'(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)