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Completed

NCT Number: NCT02477293

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

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.

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Key information

Conditions

Respiratory Tract Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Infections Rhinitis

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Female patients who are pregnant or lactating or have the chances of pregnancy
  • Patients who are participated other clinical trials within last 1 month
  • 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)
  • Patients who are judged to be inappropriate for the clinical study by the researchers

Treatment and study plan

Hyeonggaeyeongyo-tang

Drug

Other names: Hyenggaelong Granule

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. Change from baseline in total immunoglobulin E (IgE)

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

  6. Change from baseline in 'Heart Rate Variability'

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

  7. 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).

  8. 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)

  9. Change from baseline in 'Perceived Stress Scale'

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

  10. Change from baseline in eosinophil count level

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

Sponsors and collaborators

Lead sponsor

Kyung Hee University Hospital at Gangdong

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2015
Registry last updated
Dec 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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