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

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009136
• Other study ID #: ISEE_2015_SCRT
• Status: Recruiting
• Phase: Phase 3
• First received: December 28, 2016
• Last updated: March 12, 2017
• Start date: December 31, 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Kyung Hee University Hospital at Gangdong
• Contact: Youme Ko
• Phone: 822-961-9278
• Email: iseeymk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

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

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong	Dongguk University Ilsan Oriental Hospital, Kyung Hee University Hospital, Pusan National University Hospital, Semyung University Affiliated Oriental Medical Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Total Nasal Symptom score		At baseline, week 2, 4, 8, 12
Secondary	Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score		At baseline, week 2, 4, 8, 12
Secondary	Change from baseline in Total serum IgE level		At baseline, week 4
Secondary	Change from baseline in eosinophil count		At baseline, week 4
Secondary	Change from baseline in cytokine level		At baseline, week 4