Efficacy and Safety of Codonopsis lanceolata extract on the improvement of the hypersensitivity reaction in allergic rhinitis patients

Efficacy and Safety of Codonopsis lanceolata extract on the improvement of the hypersensitivity reaction in allergic rhinitis patients; A 8week, Randomized, Double blind, Placebo-controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003219

Enrollment

Registered

2018-09-27

Start date

2018-01-29

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 : 1. Test substance - Product Properties: Codonopsis lanceolata extract - Indicator material : Contains 0.1&#37

or more of Lobetyolin in one powder bag (5 ~ 6g). Codonopsis lanceolata extract 1.8 g - Excipient : Maltodextrin 2. Placebo - Product Properties : The same form as the test substance (replaced with c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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

Design outcomes

Primary

Measure	Time frame
Improvement of blood IgE level and change of T cell / B cell level	—

Secondary

Measure	Time frame
Changes in WBC count / Neutrophile / Lymphocyte / Monocyte / Basophile / Eosinophile / NK cell, changes in nasal symptom (TNSS score)	—

Countries

Korea, Republic of

Contacts

Public ContactHayoung Ahn

Semyung University Oriental Medicine Hospital

freyja21@daum.net+82-43-649-1819

Outcome results