A 4 week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of UL-F on allergic rhinitis

Not Applicable

Completed

• Conditions: Diseases of th respiratory system

• Registration Number: KCT0002004
• Lead Sponsor: STR Biotech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

(1) Patients who provided a signed written informed consent form
(2) All men and women aged between 19 and 55 years
(3) Patients with 2 years history of allergic rhinitis
(4) Visit 1&Visit 2 Nasal symptom score of the 2 type more than the score of 2 points
(5) Positive results of skin prick test
(6) Last month never received a specialty drug preion for nose symptoms

Exclusion Criteria

(1) Currently taking medication to one or more allergic diseases
(2) Consumption of Antihistamine/Corticosteroid, Antacids of H2 blocker within 2 weeks before the first visit
(3) Subjects who consumed functional foods or oriental medicine within 2 week prior to the first visit
(4) Gastric disease
(5) Patients with asthma
(6) Subject who has or experienced following diseases: myocardial infarction, stroke, cardiovascular disease
(7) alcoholic and drug addict
(8) hypertension (Systolic Blood Pressure =170 mmHg OR Diastolic Blood Pressure =100 mmHg)
(9) Diabetes (fasting glucose level = 180 mg/dL)
(10) Renal dysfunction (serum creatinine = 2 X upper limit of normal range)
(11) Liver dysfunction (AST, ALT = 2 X upper limit of normal range)
(12) Pregnancy or lactation
(13) Subjects which in the opinion investigator could affect preclude evaluation of response

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total nasal symptom scores

Secondary Outcome Measures

Name	Time	Method
Two weeks after the close ingested Total nasal symptom scores ;Specificity IgE(D. pteronyssinus, D. farinae), IL-4, IL-5, IL-10, IL-13, INF-?, Eosinophil count, Eotaxin;Rhinitis-related quality of life ;Skin Prick Test ;Adverse Event