Efficacy and Safety of Codonopsis lanceolata extract on the improvement of the hypersensitivity reaction in allergic rhinitis patients
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0003219
- Lead Sponsor
- Semyung University Oriental Medicine Hospital
- Brief Summary
In this clinical trial, the efficacy of Codonopsis lanceolata extract for the improvement of the hypersensitive immune response in subjects with allergic rhinitis was evaluated in terms of the difference between the test group and the control (placebo group). Among the primary efficacy endpoints, significant differences were observed between the experimental group and the control (placebo group) in B cell. In other words, in the test group, which was taken 8 times, the decrease in B cell of immune factors was significantly lower than that of the control group. There were no adverse events during the study period, and there were no significant clinical trial results in other safety endpoints. The results of this study confirmed the safety and efficacy of the Codonopsis lanceolata extract for improvement of hypersensitivity immunity of allergic rhintis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
? Male and female subjects aged 18 to 64 years
? Subjects with allergic rhinitis who had not been treated: TNSS assessed each item (rhinorrhea/nasal congestion/itching of nose/sneezing) more than 1 point
? The subjects who decided to voluntarily participate in the clinical trial and signed and agreed to the clinical trial agreement
? Subjects with allergies to Codonopsis lanceolata
? Subjects with upper respiratory tract infection
? Subjects with asthma
? Subjects using steroid drugs
? Subjects with acute severe cardiovascular disease such as heart failure, myocardial infarction, or stroke
? Subjects with a history of gastrointestinal disorders (eg, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test product
? Subjects who participated in other clinical studies or clinical trials within one month
? Subjects whose BUN value was more than twice the normal value
? Subjects whose ALT or AST levels exceeded the normal range by more than 3-fold
? Subjects with thyroid disease
? Subjects with serum creatinine ? 1.5 mg
? Mental illness (depression, schizophrenia, etc.)
? Subjects with drug or alcohol abuse history
? Pregnant or lactating subjects
? A person who is determined by the researcher to be inappropriate for participation in the research
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of blood IgE level and change of T cell / B cell level
- Secondary Outcome Measures
Name Time Method Changes in WBC count / Neutrophile / Lymphocyte / Monocyte / Basophile / Eosinophile / NK cell, changes in nasal symptom (TNSS score)