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

December 28, 2016 updated by: Minhee Kim, Kyung Hee University Hospital at Gangdong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05278
        • Kyung Hee University Hospital at Gangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyeonggaeyeongyo-tang
Drug: Hyeonggaeyeongyo-tang
Other Names:
  • Hyenggaelong Granule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'
Time Frame: 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
Day 2(Scheduled within a week of baseline)
Change from baseline in 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)'
Time Frame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
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
Time Frame: 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)
Day 2(Scheduled within a week of baseline)
Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test
Time Frame: Day 2(Scheduled within a week of baseline)
Observed the allergic reaction for assessing the allergenicity of patients with allergic rhinitis
Day 2(Scheduled within a week of baseline)
Change from baseline in total immunoglobulin E (IgE)
Time Frame: Day 2(Scheduled within a week of baseline), Week 5
Day 2(Scheduled within a week of baseline), Week 5
Change from baseline in 'Heart Rate Variability'
Time Frame: Day 2(Scheduled within a week of baseline), Week 5
Day 2(Scheduled within a week of baseline), Week 5
Change from Baseline in 'Ryodoraku values'
Time Frame: 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).
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)
Time Frame: Day 2(Scheduled within a week of baseline)
Day 2(Scheduled within a week of baseline)
Change from baseline in 'Perceived Stress Scale'
Time Frame: Day 2(Scheduled within a week of baseline), Week 5
Day 2(Scheduled within a week of baseline), Week 5
Change from baseline in eosinophil count level
Time Frame: Day 2(Scheduled within a week of baseline), Week 5
Day 2(Scheduled within a week of baseline), Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyung Hee University Hospital at Gangdong

Investigators

  • Study Chair: Seong-Kyu Ko, KMD, PhD, Kyunghee University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B120014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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