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

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

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

Study Overview

• Status: Unknown
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: SCRT; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05278
    • Recruiting
    • Kyung Hee University Hospital at Gangdong
    • Contact: Youme Ko, MD(TCM); Phone Number: 82-2-961-9278; Email: meyougo@khu.ac.kr
    • Principal Investigator: Minhee Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age 18-60 years
2. 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)
3. presence of nasal symptoms more than 2 consecutive years; and
4. positive reaction to the one or more perennial allergen in skin prick test.

Exclusion Criteria:

1. 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
2. presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses)
3. presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg)
4. 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))
5. presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis
6. history of drug allergy
7. history of anaphylaxis for allergic tests
8. pregnancy or lactation
9. participation of other clinical study within the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SCRT group; 3g, three times a day, each taken before or between meals	Drug: SCRT; 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)
PLACEBO_COMPARATOR: placebo group; 3g, three times a day, each taken before or between meals	Drug: Placebos; is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Total Nasal Symptom score	At baseline, week 2, 4, 8, 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score	At baseline, week 2, 4, 8, 12
Change from baseline in Total serum IgE level	At baseline, week 4
Change from baseline in eosinophil count	At baseline, week 4
Change from baseline in cytokine level	At baseline, week 4

Collaborators and Investigators

• Sponsor: Kyung Hee University Hospital at Gangdong
• Collaborators: Pusan National University Hospital; DongGuk University; Kyung Hee University Hospital; Semyung University Affiliated Oriental Medical Hospital
• Investigators: Principal Investigator: Minhee Kim, Kyung Hee University Hospital at Gangdong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 31, 2016
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (ESTIMATE): January 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 12, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Herbal Medicine; Perennial Allergic Rhinitis; Korean Medicine; So-Cheong-Ryong-Tang
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: ISEE_2015_SCRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED