Efficacy and Safety of hydrangea extract on treatment of stress Clinical Trial

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003649

Enrollment

100

Registered

2019-03-20

Start date

2017-12-22

Completion date

Unknown

Last updated

2019-03-25

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 : This material is about a composition that has a relaxation effect due to stress of hydrangea extract (HS), and the raw material used is the main purified extract of hydrangea pulc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women aged over 20 and under 75 years old 2) Persons with a stress response scale (SRI) of 50 or higher and less than 100 3) If one or more of the measures of depression/ anxiety are applicable 1 Those with a Korean-Beck Depression Inventory-II (K-BDI-II) of more than 20 points and less than 45 points 2 Those with a Korean-Beck Anxiety Inventory (K-BAI) of 16 or more points and less than 45 points 4) A person who has agreed to participate in this human application test before the human application test begins and has signed an Informed Consent form

Exclusion criteria

Exclusion criteria: 1) Those who are hospitalized, medication, and rehabilitated due to alcohol use and prevalence, heart disease, and central neuropathy through a medical history survey 2) Persons suffering from schizophrenia or with a history of disease 3) Persons with DSM-V major depression disorder 4) Those who show withdrawal from drinking and smoking

Design outcomes

Primary

Measure	Time frame
Stress Response Inventory, SRI;Korean-Beck Depression Inventory-II, K-BDI-II;Korean-Beck anxiety Inventory-II, K-BAI	—

Secondary

Measure	Time frame
Heart Rate Variability, HRV;Pittsburgh sleep quality index;Cortisol, ACTH(Adrenocorticotropic hormone)	—

Countries

Korea, Republic of

Contacts

Public ContactLim

The Catholic University of Korea

dmfq@naver.com+82-2-2001-1286

Outcome results