Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Clinical Study to Explore the Efficacy and Safety of GCJBP Laennec Inj.(Human Placenta Hydrolysate) 4ml Per Day 3 Times Per Week for 6 Weeks in the Chronic Fatigue Patients With Chronic Fatigue Syndrome or Idiopathic Chronic Fatigue
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change of Fatigue Severity Scale (FSS)
研究概览
简要总结
GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino acids, peptides, nucleobases, and carbohydrates. This product is approved for improving liver function. Also, it has been prescribed for lots of diseases such as menopausal disorders, atopic dermatitis, skin cares as well as fatigue for long time. Although its action mechanism and clinical effectiveness are not still clear, there are reports which say a strong probability of its clinical effectiveness in the chronic fatigue patients.
This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta hydrolysate) in the chronic fatigue patients through a randomized controlled tial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with chronic fatigue syndrome or idiopathic chronic fatigue
- •Given written informed consent
- •Male or female aged between 20 and 65
- •Patient who can read and answer to written questionnaires
- •Patient who agrees to visit clinic for study drug injection 3 times per a week for 6 weeks
排除标准
- •Patient who has been administrated with any other investigational product for 28 days prior to screening visit
- •Patient who is pregnant or childbearing potential female patient who does not consent for contraception during the study
- •Patient who has a hypersensitivity provoked by study drug or others drived from animals
- •Patient who has been received with any human placenta product for 6 months before study participation
- •Abnormal liver function
- •Abnormal renal function
- •Back Depression Inventory (BDI) II is more than 29
- •Underlying disease/conditions, in the investigator's judgment, which will be unable to participate in the study
研究组 & 干预措施
Placebo
NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks
干预措施: Placebo (Drug)
GCJBP Laennec Inj.
GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks
干预措施: GCJBP Laennec Inj. (Drug)
结局指标
主要结局
Change of Fatigue Severity Scale (FSS)
时间窗: Baseline and 6 weeks
次要结局
- Change per item of Fatigue Severity Scale (FSS)(Baseline, 3, 6 and 9 weeks)
- Rate of patients whose FSS decreased from 4 and more to less than 4(Baseline, 3, 6 and 9 weeks)
- Change of Visual Analogue Scale (VAS)(Baseline, 3 and 6 weeks)
- Change of Multidimensional Fatigue Inventory (MFI)(Baseline, 3 and 6 weeks)
- Global Improvement Scale (GIS)(6 weeks)
- Change in the concentration of salivary cortisol(Baseline and 6 weeks)
- Change in the concentration of interleukin-6 and interleukin 1b(Baseline and 6 weeks)
- Heart Rate Variability (HRV) parameters at resting(Baseline and 6 weeks)
- Drug compliance(6 weeks)
- Adverse Events(9 weeks)
研究者
Ho Cheol Shin, M.D., Ph.D.
Professor
Kangbuk Samsung Hospital