Climacteric SymptomsNCT03865745
Red Ginseng Extract With Climacteric Symptoms
A study testing Korean Red Ginseng in people with Climacteric Symptoms, run by MedicalExcellence.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Climacteric Symptoms
- What is being tested?
- Korean Red Ginseng
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Climacteric Symptoms
- Being tested
- Korean Red Ginseng
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red GinsengDietary supplement
Take one pack of the product (3g) once a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Korean Red Ginseng | Experimental | Product: Red ginseng Everytime 1 pack(3g/day) Receives: Dietary Supplement: Korean Red Ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota at 24 weeks vs baseline
Measured: 24 weeks
Secondary outcomes (4)
Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline
Measured: 24 weeks
Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline
Measured: 24 weeks
Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline
Measured: 24 weeks
Changes in Heart rate variability at 24 weeks vs baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedicalExcellence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865745
- Sponsor's protocol ID
- GINGAM
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03865745
- Acronym / sponsor ID
- GINGAM
- Conditions
- Climacteric Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- MedicalExcellenceUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean Red Ginseng | Experimental | Dietary Supplement: Korean Red GinsengProduct: Red ginseng Everytime 1 pack(3g/day) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean Red GinsengTake one pack of the product (3g) once a day for 24 weeks | Dietary supplement | Korean Red Ginseng |
Primary outcome
Changes in gut microbiota at 24 weeks vs baseline
Time frame: 24 weeks
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Korean Red Ginseng in people with Climacteric Symptoms, run by MedicalExcellence.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youn Ju Lee (82-2-3482-7834, yj.lee@mediex.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota at 24 weeks vs baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.