Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)

Gachon University Gil Oriental Medical Hospital

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cold Hypersensitivity

Treatments

Drug: Sipjeondaebo-tang Granule

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03374345

ISEE_2017_SDT

Details and patient eligibility

About

Gachon University, Gil Oriental Medicine Center

Enrollment

60 patients

Sex

Female

Ages

19 to 59 years old

Volunteers

No Healthy Volunteers

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

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 diagnosed with malignant tumor
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.