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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03009136
Other study ID # ISEE_2015_SCRT
Secondary ID
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
Health authority
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.

Study Design


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
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