Clinical trial NCT02477293: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Tract Diseases
Nose Diseases
Rhinitis
Keywords: Hyeonggaeyeongyo-tang
Chronic rhinitis
Pattern identification
Korean medicine
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in 'Total nasal symptom score (TNSS)'
timeFrame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
measure: Change from baseline in 'pre KiFDA-AR ver 2.0' Questionnaire
timeFrame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
Secondary outcomes:
measure: Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'
timeFrame: Day 2(Scheduled within a week of baseline)
measure: Change from baseline in 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)'
timeFrame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
measure: Pattern diagnosis by doctor of Korean medicine by traditional Korean medicine doctor's four examination
timeFrame: Day 2(Scheduled within a week of baseline)
measure: Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test
timeFrame: Day 2(Scheduled within a week of baseline)
measure: Change from baseline in total immunoglobulin E (IgE)
timeFrame: Day 2(Scheduled within a week of baseline), Week 5
measure: Change from baseline in 'Heart Rate Variability'
timeFrame: Day 2(Scheduled within a week of baseline), Week 5
measure: Change from Baseline in 'Ryodoraku values'
timeFrame: Day 2(Scheduled within a week of baseline), Week 5
measure: Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P)
timeFrame: Day 2(Scheduled within a week of baseline)
measure: Change from baseline in 'Perceived Stress Scale'
timeFrame: Day 2(Scheduled within a week of baseline), Week 5
measure: Change from baseline in eosinophil count level
timeFrame: Day 2(Scheduled within a week of baseline), Week 5
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyunghee University
name: Seong-Kyu Ko, KMD, PhD
role: STUDY_CHAIR
References:
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.