Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet
The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on
 Korean Patients With Cold Hypersensitivity in the Hands
Inclusion Criteria:

 1. Female subjects aged 19 to 59 years have a complaint of CHH.

 2. Patients must include at least one or more of the following symptoms:

 -  Those who have the symptoms of CHH in normal temperature which most individuals
 feel no cold;

 -  Those who have the symptoms of extremely cold hands in cold temperature exposure;

 -  Those who are on the return to a warmer environment, the symptoms of cold hands
 is not completely rewarmed;

 3. Those who have 4 cm or greater of VAS CHH score;

 4. A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher
 than 0.3℃;

 5. Those who can comply with all study-related procedures, medications, and evaluations;

 6. Given a written informed consent form.

 Exclusion Criteria:

 1. Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;

 2. Those who have one or more finger gangrene or ulceration;

 3. Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;

 4. Those who are diagnosed by autoimmune disease or have a positive ANA test result;

 5. Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and
 Phalen's tests;

 6. Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;

 7. Those who are diagnosed with diabetes;

 8. Those who are currently medicated to drugs that may affect to CHH symptoms, such as
 anticoagulants etc;

 9. Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100
 IU/L) or kidney dysfunction (Cr 2.0mg/dL);

 10. Those who do not (cannot) abide by treatment and follow up due to the mental illness
 such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious
 mental illness;

 11. Those who are Diagnosed with moderate anemia and hematologic disorders (adult
 non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less
 than 26%, white blood cell (WBC) level greater than 11,000/mm3);

 12. Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is
 greater than 100 mmHg based on average value of at least 2 measurements;

 13. Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart
 diseases, such as, ischemic heart disease and so on;

 14. Those who are addicted to alcohol or drugs;

 15. Those who are pregnant (positive urine-HCG) or lactating or have the chances of
 pregnancy;

 16. Those who are diagnosed with malignant tumor

 17. Those who are currently participated in other clinical trials;

 18. Those who are unable to understand and speak Korean;

 19. Those who are judged to be inappropriate for the clinical study by the researchers.