Red Ginseng Extract With Climacteric Symptoms

NCT ID: NCT03865745

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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

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Climacteric Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Korean Red Ginseng

Product: Red ginseng Everytime 1 pack(3g/day)

Group Type EXPERIMENTAL

Korean Red Ginseng

Intervention Type DIETARY_SUPPLEMENT

Take one pack of the product (3g) once a day for 24 weeks

Interventions

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Korean Red Ginseng

Take one pack of the product (3g) once a day for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedicalExcellence

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Youn Ju Lee

Role: CONTACT

82-2-3482-7834

Other Identifiers

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GINGAM

Identifier Type: -

Identifier Source: org_study_id

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