Red Ginseng Extract With Climacteric Symptoms
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|ClinicalTrials.gov Identifier: NCT03865745|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Climacteric Symptoms||Dietary Supplement: Korean Red Ginseng||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Changes in gut microbiota at 24 weeks vs baseline [ Time Frame: 24 weeks ]
- Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline [ Time Frame: 24 weeks ]
- Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline [ Time Frame: 24 weeks ]
- Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline [ Time Frame: 24 weeks ]
- Changes in Heart rate variability at 24 weeks vs baseline [ Time Frame: 24 weeks ]
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
|Contact: Youn Ju Leefirstname.lastname@example.org|