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Efficacy and Safety of KBL396 on improvement of stress; A 12 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Efficacy and Safety of KBL396 on improvement of stress; A 12 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003732
Enrollment
100
Registered
2019-04-09
Start date
2018-12-20
Completion date
Unknown
Last updated
2019-04-23

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 human subjects assigned to the test group or control group will be taken to the oral with water for a total of 12 weeks for testing food (probiotics KBL396) or 548 mg/capsules

Sponsors

Kobiolabs
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women over 20 and under 60 2) A person whose stress response inventory (SRI) scale is 50 or more and has 100 or less points 3) A person whose Korean-Beck Depression Inventory-II (K-BDI-II) scale is 14 or more and 45 or less 4) A person whose Korean-Beck Anxiety scale (K-BAI) is 8 or more points and 45 or less 5) A person who agrees to participate in this human body application test before the human body application test begins and has signed the Informational content form

Exclusion criteria

Exclusion criteria: 1) A person inpatients, medications, and rehabilitation treatment for alcohol use, induced disorder, heart disease, and central neurological disorder 2) A person who has been diagnosed with mental illness such as schizophrenia and bipolar disorder or has been diagnosed as a mental patient such as schizophrenia and bipolar disorder through Mini International Neuropsychiatric Interview(MINI) 3) A person who shows signs of abstinence from drinking, smoking, etc. 4) A person who is being treated for dementia within 3 months of the start of a test 5) A person who is being treated for depression and stress anxiety within four weeks of starting a test 6) A person who has acute stress (dead/marriage/separate/liberation/liberation/discharge/disappear/business failure/critical illness/marriage, etc.) within four weeks of the start of the test

Design outcomes

Primary

MeasureTime frame
Stress Response Inventory;Korean Beck Depression Inventory II;Korean Beck Anxiety Inventory

Secondary

MeasureTime frame
Adverse Event

Countries

Korea, Republic of

Contacts

Public ContactHong Jin Jeon

Sungkyunkwan University

jhj001001@gmail.com+82-2-3410-3586

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026