Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet

Phase 4

Completed

• Conditions: Cold Hypersensitivity
• Interventions: Drug: Korean red ginseng; Drug: Placebo

• Registration Number: NCT01664156
• Lead Sponsor: The Korean Society of Ginseng

Brief Summary

1. Objectives

1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women

2. to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography

2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity of hands and feet more effectively than placebo after 8 weeks administration of interventions- Korean red ginseng or the placebo.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-14
• Study Start: 2012-10
• Primary Completion: 2013-12
• Status Verified: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Female aged 16 to 60 years
2. Women complaining cold hypersensitivity on hands and feet
3. Thermal deviation between the palm and the upper arm is higher than 0.3℃

Exclusion Criteria

1. Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
2. Alcohol abuse and alcoholic
3. History of cancer within 5 years
4. Severe depression
5. Hypertension and diabetes
6. Pregnancy or breastfeeding
7. Abnormal finding from blood test at screening visit
8. Allergic to Korean red ginseng
9. Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Korean red ginseng	Korean red ginseng	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).
placebo	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).

Primary Outcome Measures

Name	Time	Method
The change of the infrared thermography of cold hypersensitivity on hands	baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
The change of the infrared thermography of cold hypersensitivity on feet	baseline and 8 weeks
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet	baseline and 8 weeks
The change of cold stress test	baseline and 8 weeks
The change of Distal-Dorsal Difference	baseline and 8 weeks
The change of Heart Rate Variability	baseline and 8 weeks
The change of 36-Item Short Form Health Survey	baseline, 8 weeks, and 12 weeks

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Gangdong-gu, Korea, Republic of