Cold HypersensitivityPhase 4NCT01664156
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
A Phase 4 study testing Korean red ginseng in people with Cold Hypersensitivity, run by The Korean Society of Ginseng at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women only
- Conditions the study is for
- Cold Hypersensitivity
- What is being tested?
- Korean red ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female aged 16 to 60 years
- Women complaining cold hypersensitivity on hands and feet
- Thermal deviation between the palm and the upper arm is higher than 0.3℃
Who cannot join
- Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
- Alcohol abuse and alcoholic
- History of cancer within 5 years
- Severe depression
- Hypertension and diabetes
- Pregnancy or breastfeeding
Show all 9Show fewer
- Abnormal finding from blood test at screening visit
- Allergic to Korean red ginseng
- Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, 134 727
About this study
Official title: Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial
- Objectives
- to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women
- to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography
- 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.
Read the 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.
- Conditions
- Cold Hypersensitivity
- Being tested
- Korean red ginseng, Placebo
- Keywords
- Cold hypersensitivity, Korean red ginseng, Infrared thermography, Cold stress test, Distal-dorsal difference
- Medical subject headings
- Cold Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean red ginsengDrug
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.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Korean red ginseng | 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). Receives: Drug: Korean red ginseng |
| placebo | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the infrared thermography of cold hypersensitivity on hands
Measured: baseline and 8 weeks
Secondary outcomes (6)
The change of the infrared thermography of cold hypersensitivity on feet
Measured: baseline and 8 weeks
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
Measured: baseline and 8 weeks
The change of cold stress test
Measured: baseline and 8 weeks
The change of Distal-Dorsal Difference
Measured: baseline and 8 weeks
The change of Heart Rate Variability
Measured: baseline and 8 weeks
The change of 36-Item Short Form Health Survey
Measured: baseline, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cold HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Korean Society of Ginseng
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN-MOO LEE, Kyung Hee University Hospital at Gangdong
- Investigators
- JIN-MOO LEE, Ph. D, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664156
- Sponsor's protocol ID
- KHNMC-OH-IRB 2012-004
- Status last verified
- Mar 2014
- First submitted
- 8 Aug 2012
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22856358Park KS, Kim JW, Jo JY, Hwang DS, Lee CH, Jang JB, Lee KS, Yeo I, Lee JM. Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial. Trials. 2013 Dec 19;14:438. doi: 10.1186/1745-6215-14-438.
PubMed 24354675
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01664156
- Acronym / sponsor ID
- KHNMC-OH-IRB 2012-004
- Conditions
- Cold Hypersensitivity
- Keywords
- Cold hypersensitivity, Korean red ginseng, Infrared thermography, Cold stress test, Distal-dorsal difference
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Korean Society of GinsengUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Objectives
- to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women
- to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean red ginseng | Experimental | Drug: Korean red ginsengThe 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 comparator | Drug: PlaceboPlacebo 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). |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female aged 16 to 60 years
- Women complaining cold hypersensitivity on hands and feet
- Thermal deviation between the palm and the upper arm is higher than 0.3℃
Key exclusion criteria (9 listed)
- Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
- Alcohol abuse and alcoholic
- History of cancer within 5 years
- Severe depression
- Hypertension and diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean red ginsengKorean 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. | Drug | Korean red ginseng |
| Placebo | Drug | placebo |
Primary outcome
The change of the infrared thermography of cold hypersensitivity on hands
Time frame: baseline and 8 weeks
6 secondary outcomes
The change of the infrared thermography of cold hypersensitivity on feet
Time frame: baseline and 8 weeks
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
Time frame: baseline and 8 weeks
The change of cold stress test
Time frame: baseline and 8 weeks
The change of Distal-Dorsal Difference
Time frame: baseline and 8 weeks
The change of Heart Rate Variability
Time frame: baseline and 8 weeks
The change of 36-Item Short Form Health Survey
Time frame: baseline, 8 weeks, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Background: PubMed 22856358Hur 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.
- Derived from this study: PubMed 24354675Park KS, Kim JW, Jo JY, Hwang DS, Lee CH, Jang JB, Lee KS, Yeo I, Lee JM. Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial. Trials. 2013 Dec 19;14:438. doi: 10.1186/1745-6215-14-438.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIN-MOO LEE, Ph. D principal investigator
Kyung Hee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Korean red ginseng in people with Cold Hypersensitivity, run by The Korean Society of Ginseng at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the infrared thermography of cold hypersensitivity on hands (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01664156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.