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

NCT02477293 | Completed Phase 4 DMC

• 1 other identifier: B120014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Diseases; Nose Diseases; Rhinitis

Keywords

Hyeonggaeyeongyo-tang; Chronic rhinitis; Pattern identification; Korean medicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'

  Day 2(Scheduled within a week of baseline)

• 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)

• Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test

  Day 2(Scheduled within a week of baseline)

• Change from baseline in total immunoglobulin E (IgE)

  Day 2(Scheduled within a week of baseline), Week 5

Study Arms (1)

Hyeonggaeyeongyo-tang

EXPERIMENTAL

Drug: Hyeonggaeyeongyo-tang

Interventions

Hyeonggaeyeongyo-tang DRUG

Also known as: Hyenggaelong Granule

Hyeonggaeyeongyo-tang

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age between 19 and 65 years
• Able to dialogue
• Agree with informed consent

You may not qualify if:

• 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
• Used Korean medicine for treating rhinitis within last 7 days
• Patients who has severe disease, such as malignant tumor, severe dyslipidemia, liver or kidney dysfunction, anemia, active pulmonary tuberculosis, infection or systemic disease etc
• Presence of internal nasal obstruction or nasal deformities or history of nasal surgery within 2 months
• History of active respiratory disease(ex. asthma)
• Hypertension or Diabetes
• Experienced immunotherapy or systemic steroid treatments within last 3 months
• Experienced drug allergic reactions
• Experienced anaphylactic reactions, during allergen test

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, 05278, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27698676 RESULT

MeSH Terms

Conditions

Respiratory Tract Diseases; Nose Diseases; Rhinitis

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections

Study Officials

• Seong-Kyu Ko, KMD, PhD

  Kyunghee University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KMD

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 22, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 30, 2016

Record last verified: 2016-12

Locations

KR (1)