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

Phase 4

Completed

• Conditions: Rhinitis; Respiratory Tract Diseases; Nose Diseases
• Interventions: Drug: Hyeonggaeyeongyo-tang

• Registration Number: NCT02477293
• Lead Sponsor: Kyung Hee University Hospital at Gangdong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-22
• Study Start: 2015-08
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyeonggaeyeongyo-tang	Hyeonggaeyeongyo-tang	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'	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)'	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)	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	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)	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	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)	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

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of