Official Title
Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands
Phase
Phase 4Lead Sponsor
Gachon UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cold HypersensitivityIntervention/Treatment
danggui-sayuk-ga-osuyu-saenggang-tang ...Study Participants
66The Purpose of this trial is to investigate the efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity in the Hands
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule
Inclusion Criteria: Female subjects aged 19 to 59 years have a complaint of CHH. 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; Those who have 4 cm or greater of VAS CHH score; A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃; Those who can comply with all study-related procedures, medications, and evaluations; Given a written informed consent form. Exclusion Criteria: We will exclude patients who have taken Patients with calcium antagonists or beta-blockers with the purpose of treating CHH; Those who have one or more finger gangrene or ulceration; Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs; Those who are diagnosed by autoimmune disease or have a positive ANA test result; Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests; Those who are diagnosed with cervical disc herniation or (malignant) tumor disease; Those who are diagnosed with diabetes; Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc; Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL); 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; 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); 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; Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on; Those who are addicted to alcohol or drugs; Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy; Those who are currently participated in other clinical trials; Those who are able to understand and speak Korean; Those who are judged to be inappropriate for the clinical study by the researchers.