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

Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477293
• Other study ID #: B120014
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2015
• Last updated: December 28, 2016
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: Kyung Hee University Hospital at Gangdong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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) ? 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) ? Tricyclic antidepressants, phenothiazines (drug use within lase 2 week) ? Non-steroidal analgesics (drug use within lase 1 week) ? 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nose Diseases
• Respiratory Tract Diseases
• Rhinitis

Intervention

Drug:
• Hyeonggaeyeongyo-tang

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 'Total nasal symptom score (TNSS)'		At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13	No
Primary	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	No
Secondary	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	Day 2(Scheduled within a week of baseline)	No
Secondary	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	No
Secondary	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)	Day 2(Scheduled within a week of baseline)	No
Secondary	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	Day 2(Scheduled within a week of baseline)	No
Secondary	Change from baseline in total immunoglobulin E (IgE)		Day 2(Scheduled within a week of baseline), Week 5	No
Secondary	Change from baseline in 'Heart Rate Variability'		Day 2(Scheduled within a week of baseline), Week 5	No
Secondary	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).	Day 2(Scheduled within a week of baseline), Week 5	No
Secondary	Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P)		Day 2(Scheduled within a week of baseline)	No
Secondary	Change from baseline in 'Perceived Stress Scale'		Day 2(Scheduled within a week of baseline), Week 5	No
Secondary	Change from baseline in eosinophil count level		Day 2(Scheduled within a week of baseline), Week 5	No