- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03865745
Red Ginseng Extract With Climacteric Symptoms
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Youn Ju Lee
- Phone Number: 82-2-3482-7834
- Email: yj.lee@mediex.co.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age of 40~75 men and women
- Those who visited the menopausal clinic with complaints of climacteric symptoms due to functional deterioration of various organs such as fatigue, helplessness
- 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:
- Those who have suspected symptoms of acute disease (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.)
- Patients with a history of antibiotic treatment for more than 1 month within the last 6 months
- Those who have gastrointestinal diseases (inflammatory growth disease, active peptic ulcer, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery)
- Those taking health functional foods, lactic acid bacteria, and red ginseng extracts for the past year
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Korean Red Ginseng
Product: Red ginseng Everytime 1 pack(3g/day)
|
Take one pack of the product (3g) once a day for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in gut microbiota at 24 weeks vs baseline
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline
Time Frame: 24 weeks
|
24 weeks
|
Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline
Time Frame: 24 weeks
|
24 weeks
|
Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline
Time Frame: 24 weeks
|
24 weeks
|
Changes in Heart rate variability at 24 weeks vs baseline
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GINGAM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Climacteric Symptoms
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Coordinación de Investigación en Salud, MexicoCompleted
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Inna I. KovalenkoCompletedClimacteric SyndromeRussian Federation
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National Taiwan University HospitalDepartment of HealthCompletedClimacteric Symptoms | Hot Flushes and/or Sweats
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I.M. Sechenov First Moscow State Medical UniversityCompletedPerimenopause, Climacteric SyndromeRussian Federation
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I.M. Sechenov First Moscow State Medical UniversityCompletedMenopause | Climacteric SyndromeRussian Federation
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GlaxoSmithKlineCompletedMenopausal and Female Climacteric StatesUnited States, Australia, Argentina, Germany, United Kingdom, Spain, Italy, New Zealand, Sweden
Clinical Trials on Korean Red Ginseng
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The Korean Society of GinsengCompleted
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The Korean Society of GinsengCompleted
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Daegu Catholic University Medical CenterThe Korean Society of GinsengCompletedHypertensionKorea, Republic of
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Korea Ginseng CorporationNutrasource Pharmaceutical and Nutraceutical Services, Inc.RecruitingCardiovascular Diseases | Platelet Aggregation | Vasodilation | Blood Pressure DisordersUnited States
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Unity Health TorontoCompletedMetabolic Syndrome | Type 2 DiabetesCanada
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Korea UniversityThe Korean Society of GinsengCompletedMajor Depressive DisorderKorea, Republic of
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Korea Ginseng CorporationCompletedColorectal CancerKorea, Republic of
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Seoul National University HospitalCompleted