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

Kyung Hee University

Status and phase: Completed; Phase 4

Conditions: Respiratory Tract Diseases; Rhinitis; Nose Diseases

Treatments: Drug: Hyeonggaeyeongyo-tang

Study type: Interventional

Funder types: Other

Identifiers

NCT02477293

B120014

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Hyeonggaeyeongyo-tang

Experimental group

Treatment:

Drug: Hyeonggaeyeongyo-tang