NCT03083522已完成3 期
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot Study
Chan-Yong Jeon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes from baseline in visual analogue scale
研究概览
简要总结
The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands
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 CHH.
- •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 unable 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
OJS group
Experimental
admission to Ojeok-san granule
干预措施: Ojeok-San (Drug)
Placebo Group
Placebo Comparator
admission to placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in visual analogue scale
时间窗: At baseline, week 4, 8, 12
次要结局
- Liver function tests(At screening visit, week 8)
- Changes from baseline in body temperature(At baseline, week 4, 8, 12)
- Changes from baseline in WHOQoL-BREF(At baseline, week 4, 8, 12)
- Changes from baseline in cold stress test(At baseline, week 8)
- Vital Sign(every visit)
- Kidney function test(At screening visit, week 8)
- complete blood count(At screening visit, week 8)
- Adverse event(At week 4, 8, 12)
研究者
Chan-Yong Jeon
PhD
Gachon University Gil Oriental Medical Hospital
研究点 (1)
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