Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0001766
- Lead Sponsor
- Gil Korean Medicine Hospital, Gachon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 66
Female aged 19 to 59 years have a complaint of cold hypersensitivity on hands and feet
- 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
- When subject's both upper arms exposure to room temperature (24?±2), the thermal deviation between the palm (PC8)
and the upper arm (LU4) may be higher than 0.3?
- Ability to comply with all study-related procedures, medications, and evaluations
- 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 BP 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 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 Visual Analogue Scale
- Secondary Outcome Measures
Name Time Method Body temperature;Clinical Global Impressions;Pattern Identification Questionnaire;WHO Quality of Life-BREF(WHOQOL-BREF);Cold stress test;Safety assessment (Alanine transaminase, Aspartate aminotransferase, BUN-to-creatinine ratio, complete blood count)