Multicenter clinical study of the efficacy and safety of the Ongyeong-tang(OKT) for Coldness of Feet(Cold Hypersensitivity in Feet)
- Conditions
- Not Applicable
- Registration Number
- KCT0003723
- Lead Sponsor
- Sangji University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 112
1. Female aged 19 to 59 years have a complaint of cold hypersensitivity on hands and feet
2. Subject must include at least one or more of the following symptoms below:
• Subject has the symptoms of cold hands and feet in normal temperature which most individuals feel no cold
• Subject has the symptoms of severe cold hands and feet in colder than normal temperature exposure
• Even subject is on the return to a warmer environment, the symptoms of cold hands and feet is not completely
disappeared
3. When subject's VAS(Visual Analogue Scale) of cold hypersensitivity on feet VAS) is 4 or more
4. When subject'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?
5. Ability to comply with all study-related procedures, medications, and evaluations
6. Ability to give informed consent
- Patients who are admission to calcium antagonists and beta-blockers as a treatment of cold hypersensitivity on hands
and feet
- Patients who are having one or more finger gangrene or ulceration
- Patients who are diagnosed by hyperthyroidism or currently medicated to thyroid drugs
- Patients who are diagnosed by Autoimmune disease or having a positive antinuclear antibody(ANA) test
- Patients who are diagnosed by Carpal Tunnel Syndrome or having a positive Tinel's sign and Phalen's tests
- Patients who are diagnosed with Cervical disc herniation
- Patients who are diagnosed with diabetes
- Drug that may affect to the cold hypersensitivity on hands and feet(ex. anticoagulants)
- Moderate level of liver dysfunction(each of AST, ALT greater than 100 IU/L) or kidney dysfunction patient(creatine 2.0mg/dL)
- Due to the behaviour disorder or depression or anxiety neurosis or schizophrenia or serious mental illness, do not cooperate with treatment and follow up
- Diagnosed with moderate anemia and hematologic disorders
(adult non-pregnant women hemoglobin level less than 7g/dL, hematocrit level less than 26%, white blood cell level greater than 11,000/mm3)
- Systolic blood pressure 180mmHg or diastolic blood pressure is greater than 100 mmHg based on average value of at least 2 measurements
- Suspected arrhythmia that showed up on electrocardiogram(ECG) or diagnosed by heart disease, such as, ischemic heart disease
- Alcohol or drug abuse
- Female patients who are pregnant (positive urin - human chorionic gonadotropin) or lactating or have the chances of pregnancy
- Diagnosed with malignant tumors
- Participated in other clinical trials
- Refused to participate in this trial
- Able to understand and speak Korean
- Patients who are judged to be inappropriate for the clinical study by the researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS(Visual Analogue Scale) of cold hypersensitivity on feet
- Secondary Outcome Measures
Name Time Method VAS(Visual Analogue Scale) of cold hypersensitivity on hand;Questionnaire of WHO Quality of Life Scale Abbreviated Version(WHOQOL-BREF);Temperatures of hand and feet (by check Thermometer);Cold stress test;Questionnaire of demonstration;Questionnaire of cold hypersensitivity