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  • Status : Approved
    • First Submitted Date : 2018/11/27
    • Registered Date : 2019/04/08
    • Last Updated Date : 2019/03/26
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1. Background

Background Information
CRIS
Registration Number
KCT0003723 
Unique Protocol ID SMCH-1710-16 
Public/Brief Title Multicenter clinical study of the efficacy and safety of the Ongyeong-tang(OKT) for Coldness of Feet(Cold Hypersensitivity in Feet) 
Scientific Title A Double-blind, Randomized, Placebo-controlled, pararell, Multicenter clinical Study of the efficacy and safety of the Ongyeong-tang(OKT) for Coldness of Feet(Cold Hypersensitivity in Feet)  
Acronym OKTFC 
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 1710-16 
Approval Date 2017-10-23 
Institutional Review Board  
Name Semyung Uni. ChunhJu Korean Medical Hospital IRB 
Address 63, Sangbang 4-gil, Chungju-si, Chungcheongbuk-do 
Telephone 043-841-1738 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Lee DongNyung  
Title Associate Professor 
Telephone +82-43-841-1833 
Affiliation Semyung University 
Address ChungBuk JeChen-Si Semyung-Ro 65 
Contact Person for Public Queries
Name Lee DongNyung  
Title Associate Professor 
Telephone +82-43-841-1833 
Affiliation Semyung University 
Address ChungBuk JeChen-Si Semyung-Ro 65 
Contact Person for Updating Information
Name Lee DongNyung  
Title Associate Professor 
Telephone +82-43-841-1833 
Affiliation Semyung University 
Address ChungBuk JeChen-Si Semyung-Ro 65 

4. Status

Status Information
Study Site Multi-center (Number of center : 3)
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-05-28 , Actual
Target Number of Participant 112
Primary Completion Date 2019-04-30 , Anticipated
Study Completion Date 2019-06-28 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Sangji University Oriental Medical Center 
Recruitment Status Recruiting  
Date of First Enrollment 2018-09-27 , Actual
Recruitment Status by Participating Study Site 2
Name of Study Site Semyung University Oriental Medicine Hospital 
Recruitment Status Recruiting  
Date of First Enrollment 2018-09-14 , Actual
Recruitment Status by Participating Study Site 3
Name of Study Site Chungju Oriental Hospital of Semyung University 
Recruitment Status Recruiting  
Date of First Enrollment 2018-05-28 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Ministry of Health & Welfare 
Organization Type Government  
Project ID HB1600048-010016 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Sangji University Oriental Medical Center 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Cold hypersensitivity in the hands and feet (CHHF) is a sensation of coldness in the hands and feet in an environment not considered cold by unaffected people or having a heightened cold sensation in a relatively low temperature area. OnKyeong-tang(OKT) is used as a medical treatment for Herbal medicine as a prescription to treat cold sensation of lower abdomen and lower leg in Korean medicine. The Purpose of this trial is to investigate the efficacy and safety of OnKyeong-tang(OKT) on Korean Patients With Cold Hypersensitivity in the Feet  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Drug  
Intervention Description OKT and Placebo groups take prescribed medication orally , 3g each time, 3 times per day, each taken before or between meals for 8 weeks.  
Number of Arms
Arm 1 Arm Label OKT Treatment Group 
Target Number of Participant 56 
Arm Type Experimental 
Arm Description OKT take prescribed medication orally , 3g each time, 3 times per day, each taken before or between meals for 8 weeks. 
Arm 2 Arm Label Placebo groups 
Target Number of Participant 56 
Arm Type Placebo comparator 
Arm Description Placebo groups take prescribed medication orally , 3g each time, 3 times per day, each taken before or between meals for 8 weeks. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Not Applicable
 Women who feels a cold sensation of lower leg
Cold hypersensitivity on hands and feet
Rare Disease No
Inclusion
Criteria
Gender Female 
Age 19 Year ~ 59 Year
Description 1. Female aged 19 to 59 years have a complaint of cold hypersensitivity on hands and feet <br />2. Subject must include at least one or more of the following symptoms below: <br /> • Subject has the symptoms of cold hands and feet in normal temperature which most individuals feel no cold <br /> • Subject has the symptoms of severe cold hands and feet in colder than normal temperature exposure <br /> • Even subject is on the return to a warmer environment, the symptoms of cold hands and feet is not completely <br />disappeared <br />3. When subject&#39;s VAS(Visual Analogue Scale) of cold hypersensitivity on feet VAS) is 4 or more <br />4. When subject&#39;s both upper arms exposure to room temperature (24℃±2), the thermal deviation between the foot (acupuncture point, LR3) with the thigh(acupuncture point, S32) may be higher than 2℃ <br />5. Ability to comply with all study-related procedures, medications, and evaluations <br />6. Ability to give informed consent  
Exclusion Criteria - Patients who are admission to calcium antagonists and beta-blockers as a treatment of cold hypersensitivity on hands <br />and feet <br /> - Patients who are having one or more finger gangrene or ulceration <br /> - Patients who are diagnosed by hyperthyroidism or currently medicated to thyroid drugs <br /> - Patients who are diagnosed by Autoimmune disease or having a positive antinuclear antibody(ANA) test <br /> - Patients who are diagnosed by Carpal Tunnel Syndrome or having a positive Tinel&#39;s sign and Phalen&#39;s tests <br /> - Patients who are diagnosed with Cervical disc herniation <br /> - Patients who are diagnosed with diabetes <br /> - Drug that may affect to the cold hypersensitivity on hands and feet(ex. anticoagulants) <br /> - Moderate level of liver dysfunction(each of AST, ALT greater than 100 IU/L) or kidney dysfunction patient(creatine 2.0mg/dL) <br /> - Due to the behaviour disorder or depression or anxiety neurosis or schizophrenia or serious mental illness, do not cooperate with treatment and follow up <br /> - Diagnosed with moderate anemia and hematologic disorders <br />(adult non-pregnant women hemoglobin level less than 7g/dL, hematocrit level less than 26&#37;, white blood cell level greater than 11,000/mm3) <br /> - Systolic blood pressure 180mmHg or diastolic blood pressure is greater than 100 mmHg based on average value of at least 2 measurements <br /> - Suspected arrhythmia that showed up on electrocardiogram(ECG) or diagnosed by heart disease, such as, ischemic heart disease <br /> - Alcohol or drug abuse <br /> - Female patients who are pregnant (positive urin - human chorionic gonadotropin) or lactating or have the chances of pregnancy <br /> - Diagnosed with malignant tumors <br /> - Participated in other clinical trials <br /> - Refused to participate in this trial <br /> - Able to understand and speak Korean <br /> - Patients who are judged to be inappropriate for the clinical study by the researchers  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome VAS(Visual Analogue Scale) of cold hypersensitivity on feet 
Timepoint Week 0, Week 8, Week 12 
Secondary Outcome(s) 1 
Outcome VAS(Visual Analogue Scale) of cold hypersensitivity on hand 
Timepoint Week 0, 4, Week 8, Week 12 
Secondary Outcome(s) 2 
Outcome Questionnaire of WHO Quality of Life Scale Abbreviated Version(WHOQOL-BREF) 
Timepoint Week 0, Week 8, Week 12 
Secondary Outcome(s) 3 
Outcome Temperatures of hand and feet (by check Thermometer) 
Timepoint Week 0, Week 8, Week 12 
Secondary Outcome(s) 4 
Outcome Cold stress test 
Timepoint Week 0, Week 8, Week 12 
Secondary Outcome(s) 5 
Outcome Questionnaire of demonstration 
Timepoint Week 0 
Secondary Outcome(s) 6 
Outcome Questionnaire of cold hypersensitivity 
Timepoint Week 0, Week 8, Week 12 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Yes 
Time of Sharing 2022.12
Way of Sharing Available on Request
(handr88@korea.com)
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