Completed

Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial

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What is being tested

Korean red ginseng

+ Placebo

Drug
Who is being recruted

From 16 to 60 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorThe Korean Society of Ginseng
Last updated: March 14, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

Design This trial is a randomized, double blind, placebo controlled trial with 80 patients. The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea. Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up during 4 weeks. During the administration period, 6 capsules 2 times a day (1h after breakfast and dinner) of Korean red ginseng or its placebo will be provided.

NCT01664156
Principal SponsorThe Korean Society of Ginseng
Last updated: March 14, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 16 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Female aged 16 to 60 years
Thermal deviation between the palm and the upper arm is higher than 0.3°C
Women complaining cold hypersensitivity on hands and feet
9 exclusion criteria prevent from participating
Abnormal finding from blood test at screening visit
Alcohol abuse and alcoholic
Allergic to Korean red ginseng
History of cancer within 5 years
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea). Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).

Group II

Placebo
Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng. Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kyung Hee University Hospital at Gangdong

Seoul, South KoreaOpen Kyung Hee University Hospital at Gangdong in Google Maps
CompletedOne Study Center