Efficacy and Safety of Rosa multiflora Thunberg Extracts on allergic rhinitis; Placebo-Clinical Trial

Efficacy and safety of Rosa multiflora Thunberg Extracts on allergic rhinitis; A 4week, Double-blind, Randomized, Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001843

Enrollment

Registered

2016-03-14

Start date

2016-03-18

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: Rosa multiflora Thunberg Extracts 485 mg/2 tab*2 *2time/1day, 4 weeks Placebo group: placebo 2 tab*2 *2time/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 60 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 prescription 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 and D. farinae);Eosinophil count;Eotaxin;IL-4, IL-5, IL-10, IL-13, INF-?;Eosinophil percentage;Rhinitis-related quality of life;Skin Prick Test	—

Countries

Korea, Republic of

Contacts

Public ContactChul-Hee Gu

Seoul National University Hospital

Outcome results