Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial

• Status: Completed
• Trial end date: 2019-09-14
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: Kyung Hee University Hospital at Gangdong; Kyunghee University Medical Center; Sangji University Oriental Medical Hospital; Semyung University Affiliated Oriental Medical Hospital

Criteria

Inclusion Criteria:

• Female subjects aged 19 to 59 years have a complaint of CHHF.

• 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.