KCT0003723招募中未知
A Double-blind, Randomized, Placebo-controlled, pararell, Multicenter clinical Study of the efficacy and safety of the Ongyeong-tang(OKT) for Coldness of Feet(Cold Hypersensitivity in Feet)
Sangji University Oriental Medical Center0 个研究点目标入组 112 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 59(Year)（—）
- 性别
- Female
入选标准
- •1. Female aged 19 to 59 years have a complaint of cold hypersensitivity on hands and feet
- •2. Subject must include at least one or more of the following symptoms below:
- •Subject has the symptoms of cold hands and feet in normal temperature which most individuals feel no cold
- •Subject has the symptoms of severe cold hands and feet in colder than normal temperature exposure
- •Even subject is on the return to a warmer environment, the symptoms of cold hands and feet is not completely
- •disappeared
- •3. When subject's VAS(Visual Analogue Scale) of cold hypersensitivity on feet VAS) is 4 or more
- •4. When subject's both upper arms exposure to room temperature (24?±2), the thermal deviation between the foot (acupuncture point, LR3) with the thigh(acupuncture point, S32) may be higher than 2?
- •5. Ability to comply with all study-related procedures, medications, and evaluations
- •6. Ability to give informed consent
排除标准
- •- Patients who are admission to calcium antagonists and beta-blockers as a treatment of cold hypersensitivity on hands
- •- Patients who are having one or more finger gangrene or ulceration
- •- Patients who are diagnosed by hyperthyroidism or currently medicated to thyroid drugs
- •- Patients who are diagnosed by Autoimmune disease or having a positive antinuclear antibody(ANA) test
- •- Patients who are diagnosed by Carpal Tunnel Syndrome or having a positive Tinel's sign and Phalen's tests
- •- Patients who are diagnosed with Cervical disc herniation
- •- Patients who are diagnosed with diabetes
- •- Drug that may affect to the cold hypersensitivity on hands and feet(ex. anticoagulants)
- •- Moderate level of liver dysfunction(each of AST, ALT greater than 100 IU/L) or kidney dysfunction patient(creatine 2.0mg/dL)
- •- Due to the behaviour disorder or depression or anxiety neurosis or schizophrenia or serious mental illness, do not cooperate with treatment and follow up
- •- Diagnosed with moderate anemia and hematologic disorders
- •(adult non-pregnant women hemoglobin level less than 7g/dL, hematocrit level less than 26%, white blood cell level greater than 11,000/mm3)
- •- Systolic blood pressure 180mmHg or diastolic blood pressure is greater than 100 mmHg based on average value of at least 2 measurements
- •- Suspected arrhythmia that showed up on electrocardiogram(ECG) or diagnosed by heart disease, such as, ischemic heart disease
- •- Alcohol or drug abuse
- •- Female patients who are pregnant (positive urin - human chorionic gonadotropin) or lactating or have the chances of pregnancy
- •- Diagnosed with malignant tumors
- •- Participated in other clinical trials
- •- Refused to participate in this trial
- •- Able to understand and speak Korean
- •- Patients who are judged to be inappropriate for the clinical study by the researchers
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