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

Cold Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664156
• Other study ID #: KHNMC-OH-IRB 2012-004
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2012
• Last updated: March 12, 2014
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: The Korean Society of Ginseng
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cold Hypersensitivity
• Cryopyrin-Associated Periodic Syndromes
• Hypersensitivity

Intervention

Drug:
• Korean red ginseng
Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng.
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul	Gangdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
The Korean Society of Ginseng

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Hur YM, Chae JH, Chung KW, Kim JJ, Jeong HU, Kim JW, Seo SY, Kim KS. Feeling of cold hands and feet is a highly heritable phenotype. Twin Res Hum Genet. 2012 Apr;15(2):166-9. doi: 10.1375/twin.15.2.166. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of the infrared thermography of cold hypersensitivity on hands		baseline and 8 weeks	No
Secondary	The change of the infrared thermography of cold hypersensitivity on feet		baseline and 8 weeks	No
Secondary	The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet		baseline and 8 weeks	No
Secondary	The change of cold stress test		baseline and 8 weeks	No
Secondary	The change of Distal-Dorsal Difference		baseline and 8 weeks	No
Secondary	The change of Heart Rate Variability		baseline and 8 weeks	No
Secondary	The change of 36-Item Short Form Health Survey		baseline, 8 weeks, and 12 weeks	No