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Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults

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ClinicalTrials.gov Identifier: NCT03775837
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

Brief Summary:
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Panax Ginseng C.A. Mey Extract on liver function in adults for 8 weeks.

Condition or disease Intervention/treatment Phase
Liver Diseases Dietary Supplement: Panax Ginseng C.A. Mey Extract group Dietary Supplement: Placebo group Not Applicable

Detailed Description:
Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to improve liver function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Panax Ginseng C.A. Mey Extract on liver function in adults; the safety of the compound are also evaluate. The Investigators examine AST, ALT, GGT, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Panax Ginseng C.A. Mey Extract or a placebo each day for 8 weeks;

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults: a Randomized, Double-blinded, Placebo-controlled Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Panax Ginseng C.A. Mey Extract group
This group takes Panax Ginseng C.A. Mey Extract for 8 weeks
Dietary Supplement: Panax Ginseng C.A. Mey Extract group
This group takes Panax Ginseng C.A. Mey Extract for 8 weeks

Placebo Comparator: Placebo group
This group takes placebo for 8 weeks
Dietary Supplement: Placebo group
This group takes placebo for 8 weeks




Primary Outcome Measures :
  1. Alanine aminotransferase [ Time Frame: 8 weeks ]
    Alanine aminotransferase


Secondary Outcome Measures :
  1. Aspartate aminotransferase [ Time Frame: 8 weeks ]
    Aspartate aminotransferase

  2. Gamma-glutamyl transferase [ Time Frame: 8 weeks ]
    Gamma-glutamyl transferase



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ALT ranging from upper limit of reference to three times of upper limit

Exclusion Criteria:

  • Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
  • Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
  • History of viral hepatitis or cancer
  • Uncontrolled hypertension
  • History of serious cardiac disease such as angina or myocardial infarction
  • History of gastrectomy
  • History of medication for psychiatric disease
  • Administration of oriental medicine including herbs within the past 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775837


Contacts
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Contact: Sang Yeoup Lee 360-2860 ext 055 saylee@pnu.edu
Contact: Ye Li Lee 360-2860 ext 055 yeri1230@gmail.com

Locations
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Korea, Republic of
Integrated Research Institute for Natural Ingredients and Functional Foods Recruiting
Yangsan, Korea, Republic of, 50612
Contact: Sang Yeoup Lee, MD    82-55-360-2860    saylee@pnu.edu   
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital

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Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03775837     History of Changes
Other Study ID Numbers: 02-2018-031
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases