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

NCT ID: NCT02477293

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Respiratory Tract Diseases Nose Diseases Rhinitis

Keywords

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Hyeonggaeyeongyo-tang Chronic rhinitis Pattern identification Korean medicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyeonggaeyeongyo-tang

Group Type EXPERIMENTAL

Hyeonggaeyeongyo-tang

Intervention Type DRUG

Interventions

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Hyeonggaeyeongyo-tang

Intervention Type DRUG

Other Intervention Names

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Hyenggaelong Granule

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role lead

Responsible Party

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Minhee Kim

KMD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seong-Kyu Ko, KMD, PhD

Role: STUDY_CHAIR

Kyunghee University

Locations

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Kyung Hee University Hospital at Gangdong

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 27698676 (View on PubMed)

Other Identifiers

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B120014

Identifier Type: -

Identifier Source: org_study_id