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The effectiveness and safety of Hyeonggaeyeongyo-tang for chronic rhinitis according to pattern identification in Korean medicine

Not Applicable
Completed
Conditions
Diseases of th respiratory system
Registration Number
KCT0001544
Lead Sponsor
Kyung Hee University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
Inclusion Criteria

1) Patients who are diagnosed by moderate level of allergic 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 > 19
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)
? 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)
? Tricyclic antidepressants, phenothiazines (drug use within lase 2 week)
? Non-steroidal analgesics (drug use within lase 1 week)
? 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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total nasal symptom score (TNSS) ;pre KiFDA-AR ver 2.0
Secondary Outcome Measures
NameTimeMethod
Skin prick test;Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ);Pattern Diagnosis by Doctor of Korean Medicine;Cold-heat Pattern Identification Questionnaire;Total Immunoglobulin E;Heart Rate Variability;Ryodoraku Objectives;Waters, Caldwell, and lateral view (paranasal sinus 3P) X-ray ;Perceived Stress Scale;Eosinophil count
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