Overview

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.