Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids

Chonbuk National University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hyperlipidemia

Treatments: Dietary Supplement: Kochujang Pills; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01735149

SRCM-HL-KOCHUJANG

Details and patient eligibility

About

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females 19-55 years old
• Total Cholesterol 200~260 mg/dl or LDL-C 110~190 mg/dl
• Able to give informed consent

Exclusion criteria

• Allergic or hypersensitive to any of the ingredients in the test products
• History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
• History of alcohol or substance abuse
• Participation in any other clinical trials within past 2 months
• Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
• Pregnant or lactating women etc.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Kochujang Pills

Experimental group

Treatment:

Dietary Supplement: Kochujang Pills

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo