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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002004

Enrollment

Registered

2016-08-12

Start date

2015-03-26

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The participants enrolled in this study was assigned to 2 groups by double-blinde randomization

Test group: UL-F 2 cap * 3 times/1day, 4 weeks Placebo group: placebo 2 cap* 3 times/1day, 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Total nasal symptom scores	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactHye-Ryun Kang

Seoul National University Hospital

helenmed@hanmail.net

Outcome results