Clinical Trial for the Evaluation of the Efficacy and Safety of LHF618 on Allergic rhinitis
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0006522
- Lead Sponsor
- WiLab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 120
1) Subjects between 19 ~65 years of age
2) Persons with allergic rhinitis who are at least 2 years of intermittent
3) Those who have above two points in more than two nasal symptoms * (snoring, sneezing, watery rhinorrhea, nasal congestion) in the run-in period between visit 1 and visit 2.(*Can participate when satisfied with morning or evening or average morning and evening scores )
4) Allergic skin prick test results showed positive reaction
5) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
1) Currently taking medication to allergic diseases
2) Subjects who consumed antihistamine/antiallergic drug, of H2 blocker within 2 weeks before the visit 1
3) Subjects who consumed functional foods or oriental medicine for improvement of allergic rhinitis of within 2 weeks before the visit 1
4) Subject who was taking drugs steroid for the whole body or the nasal cavity within 1 month before the visit 1
5) Subject who was taking allergen immunotherapy within 1 month before the visit 1
6) Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the last 6 months(However, patients who have a history of cerebrovascular disease or heart disease but are clinically stable can participate in the test by the judgment of the investigator)
7) Currently undergoing gastritis and gastric ulcer, asthma treatment
8) People with mental disorders such as depression, schizophrenia, alcoholism, drug addiction
9) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization)
10) Unregulated diabetic patients(fasting blood sugar over 180 mg/dL)
11) Subject who more than 2 times the upper limit of normal Creatinine of clinical trial institution
12) Subject who more than 3 times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution
13) Subject with severe gastrointestinal disturbances who are suffering from ingestion of test food
14) Any person who is pregnant or who has a pregnancy plan for the duration of the trial
15) If you have participated in another clinical trial within one month of the start of this clinical trial or plan to participate in another clinical trial during the trial period
16) Subject sensitive or allergic to the investigational product
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Nasal Symptom Score after 4 weeks of ingestion
- Secondary Outcome Measures
Name Time Method Total Nasal Symptom Score after 2 weeks of ingestion;Total Nasal Symptom Score after 2 weeks the end of intake;Specific IgE, total IgE;Eosinophil count;Eotaxin;IL-4, IL-5, IL-10, IL-13, INF-?;Urine leukotriene;RQoL(Rhinitis Quality of Life);RCAT(Rhinitis Control Assessment Test);Skin prick test