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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hyeonggaeyeongyo-tang
Drug: Hyeonggaeyeongyo-tang
Other Names:
  • Hyenggaelong Granule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyung Hee University Hospital at Gangdong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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