A human trial to evaluate the efficacy and safety of Rhus verniciflua Stokes and Eucommia ulmoides Oliver extract mixtures on improvement of Liver function

A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Rhus verniciflua Stokes and Eucommia ulmoides Oliver extract mixtures on improvement of Liver function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004552

Enrollment

120

Registered

2019-12-12

Start date

2018-11-09

Completion date

Unknown

Last updated

2019-12-16

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 : Rhus verniciflua Stokes and Eucommia ulmoides Oliver extract mixtures group: twice a day, 2 tablets once, before breakfast or dinner, for 12 weeks(3.6g/day, 1.2g/day for Rhus vern

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Males and females aged 19-70 years at the screening examination 2)Participants with 45=Alanine Transaminase(ALT)=135 (U/L) 3)Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion criteria

Exclusion criteria: 1)Patients with a clinically significant disease requiring treatment (i.e., acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, kidney and urinary system, neuropsychiatric system, musculoskeletal inflammation, inflammatory disease, blood and tumor disease, gastrointestinal disease, etc.) 2)Patients who take medicine for improvement of liver function and intake health functional food within a month prior to the screening examination 3)Patients with a history of antipsychotic medication use within 3 months prior to the screening examination 4)Patients with a history of clinically significant hypersensitivity reactions to drugs and test products 5)Patients who have participated in other clinical trials within 3 months prior to the screening examination 6)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Design outcomes

Primary

Measure	Time frame
ALT (Alanine Transaminase);GGT (Gamma-glutamyl transferase)	—

Secondary

Measure	Time frame
liver function index;Lipids Metabolism index;steatosis index;Antioxidant index;MFS(Multidimensional Fatigue Scale)	—

Countries

Korea, Republic of

Contacts

Public ContactSoo jung Park

Woosuk University Korean Medicine Medical Center

taorgi@hanmail.net+82-63-220-8676

Outcome results