NCT03790033已完成2 期
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
Gachon University Gil Oriental Medical Hospital1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年12月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Changes from baseline in visual analogue scale(VAS)
研究概览
简要总结
To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
UCHA group
Experimental
2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company
干预措施: Ucha-Shinki-Hwan (Drug)
Placebo group
Placebo Comparator
2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in visual analogue scale(VAS)
时间窗: At baseline, week 4, 8, 12
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
次要结局
- Changes from baseline in body temperature(At baseline, week 4, 8, 12)
- Changes from baseline in blood pressure(up to 12 weeks)
- Changes from baseline in Pulse rate(up to 12 weeks)
- Changes from baseline in WHO Quality of Life-BREF(At baseline, week 4, 8, 12)
- Levels of AST(At screening visit, week 8)
- Levels of ALT(Kidney function test for monitoring patient safety(mmol/L))
- Levels of r-GTP(Kidney function test for monitoring patient safety(mmol/L))
- Levels of BUN(Kidney function test for monitoring patient safety(mmol/L))
- Levels of Cr(Kidney function test for monitoring patient safety(mmol/L))
- Adverse event(At week 4, 8, 12)
研究者
Chan-Yong Jeon
Principal Investigator
Gachon University Gil Oriental Medical Hospital
研究点 (1)
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