Efficacy and safety of AKE affecting decreases in postprandial blood sugar; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002617

Enrollment

Registered

2017-12-26

Start date

2017-09-04

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 : Leaves of Aster koraiensis 750mg group or placebo 750mg group ? oral intake with water twice a day, each time 3tablets

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Male and female subject aged between 20 years and 75 years (2) Subjests with a fasting blood glucose below 125mg/dL (3) Subjects who agree to participate in the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: (1) Subjects with severe cerebrovascular disease(cerebral infarction, stroke etc), heart disease(angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the 6 months prior to screening. ? In the case of clinically stable subjects, the test may be conducted at the discretion of professor. (2) Subjects who taking insulin treatments, hypoglycemic agents within the 3 months prior to screening. (3) Subjects who have taken corticosteroids within 2 months of the start of the study (4) An uncontrolled thyroid patient (5) Serum creatinine = 2 times the upper limit of normal (6) Serum AST(GOT) or ALT(GPT) = 3 times the upper limit of normal (7) Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia (8) Subjects with CNS disorder (depressive disorder, schizophrenia, alcoholism, drug addiction) (9) Subjects which in the opinion investigator could affect preclude evaluation of response. (10) Women who are pregnant or lactating or planning to get pregnant (11) Subjects who have a plan to participate in other clinical trial (12) Participation in any clinical trial within the 3 months prior to screening

Design outcomes

Primary

Measure	Time frame
Fastng plasma glucose;2-Hour Postprandial glucose level;Oral Glucose Tolerance Test, AUC 0~2hr;HbA1c;Insulin;Connecting peptide;HOMA-Insulin resistance(IR), HOMA-ß, Quantitative insulin sensitivity check index(QUICKI)	—

Secondary

Measure	Time frame
Treatment-Emergent Adverse Events, TEAEs;Clinical pathology examination;pulse, blood pressure, body weight;electrocardiography	—

Countries

Korea, Republic of

Contacts

Public ContactMisuk Kang

Hallym University Medical Center

any5corea@gmail.com+82-31-380-3770

Outcome results