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Respiratory Tract DiseasesPhase 4NCT02477293

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

A Phase 4 study testing Hyeonggaeyeongyo-tang in people with Respiratory Tract Diseases and Nose Diseases, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 years
What is being tested?
Hyeonggaeyeongyo-tang
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
Aug 2015to Jan 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Hospital at Gangdong

    Seoul, Seoul, 05278

Other trials in South Korea

About this study

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.

Being tested
Hyeonggaeyeongyo-tang
Keywords
Hyeonggaeyeongyo-tang, Chronic rhinitis, Pattern identification, Korean medicine
Medical subject headings
Respiratory Tract Diseases, Nose Diseases, Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyeonggaeyeongyo-tangDrug

    Also called Hyenggaelong Granule

Study groups in NCT02477293
Study groupRoleWhat they receive
Hyeonggaeyeongyo-tangExperimentalNot described
Receives: Drug: Hyeonggaeyeongyo-tang

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in 'Total nasal symptom score (TNSS)'

    Measured: 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

    Measured: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13

Secondary outcomes (10)

  1. Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'

    Pattern Diagnosis(either cold or heat pattern) based on the results of Cold-heat Pattern Identification Questionnaire

    Measured: Day 2(Scheduled within a week of baseline)

  2. Change from baseline in 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)'

    Measured: 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

    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)

    Measured: Day 2(Scheduled within a week of baseline)

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

    Observed the allergic reaction for assessing the allergenicity of patients with allergic rhinitis

    Measured: Day 2(Scheduled within a week of baseline)

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

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

  6. Change from baseline in 'Heart Rate Variability'

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

  7. Change from Baseline in 'Ryodoraku values'

    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).

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

  8. Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P)

    Measured: Day 2(Scheduled within a week of baseline)

  9. Change from baseline in 'Perceived Stress Scale'

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

  10. Change from baseline in eosinophil count level

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477293
Sponsor's protocol ID
B120014
Status last verified
Dec 2016
First submitted
10 Jun 2015
Last updated
30 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27698676

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hyeonggaeyeongyo-tang in people with Respiratory Tract Diseases and Nose Diseases, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02477293, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.

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