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.
1 other identifier
interventional
53
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMarch 7, 2019
March 1, 2019
11 months
March 4, 2019
March 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in gut microbiota at 24 weeks vs baseline
24 weeks
Secondary Outcomes (4)
Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline
24 weeks
Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline
24 weeks
Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline
24 weeks
Changes in Heart rate variability at 24 weeks vs baseline
24 weeks
Study Arms (1)
Korean Red Ginseng
EXPERIMENTALProduct: Red ginseng Everytime 1 pack(3g/day)
Interventions
Take one pack of the product (3g) once a day for 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 7, 2019
Study Start
March 1, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
March 7, 2019
Record last verified: 2019-03