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Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis

Primary Purpose

Perennial Allergic Rhinitis

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SCRT

Placebos

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Perennial Allergic Rhinitis, Herbal Medicine, Korean Medicine, So-Cheong-Ryong-Tang

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 18-60 years
presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score ≥ 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom)
presence of nasal symptoms more than 2 consecutive years; and
positive reaction to the one or more perennial allergen in skin prick test.

Exclusion Criteria:

treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week
presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses)
presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg)
presence of abnormal liver function (aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) ≥ 30 mg/dL or creatinine ≥ 1.8 mg/dL (male), 1.5 mg/dL (female))
presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis
history of drug allergy
history of anaphylaxis for allergic tests
pregnancy or lactation
participation of other clinical study within the past 3 months.

Sites / Locations

Kyung Hee University Hospital at GangdongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SCRT group

placebo group

Arm Description

3g, three times a day, each taken before or between meals

Outcomes

Primary Outcome Measures

Change from baseline in Total Nasal Symptom score

Secondary Outcome Measures

Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

Change from baseline in Total serum IgE level

Change from baseline in eosinophil count

Change from baseline in cytokine level

Full Information

NCT ID

NCT03009136

First Posted

December 28, 2016

Last Updated

March 12, 2017

Sponsor

Kyung Hee University Hospital at Gangdong

Collaborators

Kyung Hee University Hospital, Pusan National University Hospital, Semyung University Affiliated Oriental Medical Hospital, DongGuk University

1. Study Identification

Unique Protocol Identification Number

NCT03009136

Brief Title

Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis

Official Title

Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis: Study Protocol for a Double-blind, Randomized, Parallel-group, Multi-center Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 31, 2016 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyung Hee University Hospital at Gangdong

Collaborators

Kyung Hee University Hospital, Pusan National University Hospital, Semyung University Affiliated Oriental Medical Hospital, DongGuk University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perennial Allergic Rhinitis

Keywords

Perennial Allergic Rhinitis, Herbal Medicine, Korean Medicine, So-Cheong-Ryong-Tang

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SCRT group

Arm Type

Experimental

Arm Description

3g, three times a day, each taken before or between meals

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm Description

3g, three times a day, each taken before or between meals

Intervention Type

Drug

Intervention Name(s)

SCRT

Intervention Description

composed of eight herbs: Glycyrrhiza uralensis Fischer 1g Zingiber officinale Roscoe 0.5g Cinnamomum cassia Blume 0.2g, Ephedra sinica Stapf 0.5g, Pinellia ternata Breitenbach 2.67g, Paeonia lactiflora PALL 1g, Asiasarum sieboldi F. Maekawa 0.5g, Schisandra chinensis 2.67g (per 9g of granules)

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT

Primary Outcome Measure Information:

Title

Change from baseline in Total Nasal Symptom score

Time Frame

At baseline, week 2, 4, 8, 12

Secondary Outcome Measure Information:

Title

Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

Time Frame

At baseline, week 2, 4, 8, 12

Title

Change from baseline in Total serum IgE level

Time Frame

At baseline, week 4

Title

Change from baseline in eosinophil count

Time Frame

At baseline, week 4

Title

Change from baseline in cytokine level

Time Frame

At baseline, week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18-60 years presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score ≥ 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom) presence of nasal symptoms more than 2 consecutive years; and positive reaction to the one or more perennial allergen in skin prick test. Exclusion Criteria: treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses) presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg) presence of abnormal liver function (aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) ≥ 30 mg/dL or creatinine ≥ 1.8 mg/dL (male), 1.5 mg/dL (female)) presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis history of drug allergy history of anaphylaxis for allergic tests pregnancy or lactation participation of other clinical study within the past 3 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Youme Ko

Phone

822-961-9278

iseeymk@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minhee Kim

Organizational Affiliation

Kyung Hee University Hospital at Gangdong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyung Hee University Hospital at Gangdong

City

Seoul

ZIP/Postal Code

05278

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Youme Ko, MD(TCM)

Phone

82-2-961-9278

meyougo@khu.ac.kr

First Name & Middle Initial & Last Name & Degree

Minhee Kim

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28963290

Citation

Kim MH, Ko Y, Ahn JH, Yun Y, Yun MN, Ko SG, Choi I. Efficacy and safety of So-Cheong-Ryong-Tang in treatment of perennial allergic rhinitis: study protocol for a double-blind, randomised, parallel-group, multicentre trial. BMJ Open. 2017 Sep 27;7(9):e016556. doi: 10.1136/bmjopen-2017-016556.

Results Reference

derived

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Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis

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