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

The Korean Society of Ginseng

Status and phase: Completed; Phase 4

Conditions: Cold Hypersensitivity

Treatments: Drug: Korean red ginseng; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01664156

KHNMC-OH-IRB 2012-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

Korean red ginseng

Experimental group

Description:

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).

Treatment:

Drug: Korean red ginseng

placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo