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Red Ginseng Extract With Climacteric Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03865745
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
MedicalExcellence

Brief Summary:
The purpose of this study is to investigate the positive effects of red ginseng extract on intestinal bacterial changes and immunity, free radicals, antioxidant capacity, and autonomic nervous system changes in age of 40~75 men and women with climacteric symptoms for 24 weeks.

Condition or disease Intervention/treatment Phase
Climacteric Symptoms Dietary Supplement: Korean Red Ginseng Not Applicable

Detailed Description:

A screening test is conducted for those who have agreed in writing with a detailed explanation of the purpose of this study and research methods, and then a person who meets the selection / exclusion criteria is selected.

Give a registration number to the person selected as the subject through the screening, and take one pack of the product (3g) once a day for 24 weeks in a human body application test.

Prior to taking the registration number (1Day), the efficacy evaluation items and the safety evaluation items are carried out. At the 24 weeks after the starting point of taking the product of human application test, the evaluation items are conducted through outpatient visits.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-week, Single-center, Open-label Study to Evaluate Gut Microbiota, Immunity, Oxidative Stress and Autonomic Nerve System of Red Ginseng Extract in Subjects With Climacteric Symptoms.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Korean Red Ginseng
Product: Red ginseng Everytime 1 pack(3g/day)
Dietary Supplement: Korean Red Ginseng
Take one pack of the product (3g) once a day for 24 weeks




Primary Outcome Measures :
  1. Changes in gut microbiota at 24 weeks vs baseline [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline [ Time Frame: 24 weeks ]
  2. Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline [ Time Frame: 24 weeks ]
  3. Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline [ Time Frame: 24 weeks ]
  4. Changes in Heart rate variability at 24 weeks vs baseline [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 40~75 men and women
  2. Those who visited the menopausal clinic with complaints of climacteric symptoms due to functional deterioration of various organs such as fatigue, helplessness
  3. Those who have agreed to voluntarily decide to participate and observe the instructions after hearing the detailed explanation of this human body application test

Exclusion Criteria:

  1. Those who have suspected symptoms of acute disease (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.)
  2. Patients with a history of antibiotic treatment for more than 1 month within the last 6 months
  3. Those who have gastrointestinal diseases (inflammatory growth disease, active peptic ulcer, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery)
  4. Those taking health functional foods, lactic acid bacteria, and red ginseng extracts for the past year
  5. Those who are currently participating in other clinical studies or human trials, or participating in clinical trials or human application tests within the past month

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): NCT03865745


Contacts
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Contact: Youn Ju Lee 82-2-3482-7834 yj.lee@mediex.co.kr

Sponsors and Collaborators
MedicalExcellence

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Responsible Party: MedicalExcellence
ClinicalTrials.gov Identifier: NCT03865745     History of Changes
Other Study ID Numbers: GINGAM
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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