Red Ginseng Extract With Climacteric Symptoms | NCT03865745

Studies
Red Ginseng Extract With Climacteric Symptoms

NCT03865745

Sponsor

MedicalExcellence

Status

Unknown status

Last Update Posted

Mar 7, 2019Actual

Enrollment

53Estimated

Phase

Not Applicable

Conditions

Climacteric Symptoms

Interventions

Korean Red Ginseng

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2019Estimated

Primary Completion Date

Feb 2020Estimated

Completion Date

Feb 2020Estimated

First Submitted Date

Mar 4, 2019

First Submission Date that Met QC Criteria

Mar 5, 2019

First Posted Date

Mar 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2019

Last Update Posted Date

Mar 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Korean Red Ginseng	Experimental	Product: Red ginseng Everytime 1 pack(3g/day)	Dietary Supplement: Korean Red Ginseng

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Korean Red Ginseng	Dietary Supplement	Take one pack of the product (3g) once a day for 24 weeks	Korean Red Ginseng

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in gut microbiota at 24 weeks vs baseline		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided