Status:
COMPLETED
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
Lead Sponsor:
Gachon University Gil Oriental Medical Hospital
Collaborating Sponsors:
Kyunghee University Medical Center
Kyung Hee University Hospital at Gangdong
Conditions:
Cold Hypersensitivity
Eligibility:
FEMALE
19-59 years
Phase:
PHASE2
PHASE3
Brief Summary
To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2019
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT03790033
Start Date
December 11 2018
End Date
September 14 2019
Last Update
September 1 2021
Active Locations (1)
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1
Kyung Hee University medical center at Gangdong
Seoul, South Korea, 02447