Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients
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.
Chronic Fatigue Syndrome
Idiopathic Chronic Fatigue
Drug: GCJBP Laennec Inj.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Change of Fatigue Severity Scale (FSS) [ Time Frame: Baseline and 6 weeks ]
- Change per item of Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 3, 6 and 9 weeks ]
- Rate of patients whose FSS decreased from 4 and more to less than 4 [ Time Frame: Baseline, 3, 6 and 9 weeks ]
- Change of Visual Analogue Scale (VAS) [ Time Frame: Baseline, 3 and 6 weeks ]
- Change of Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 3 and 6 weeks ]
- Global Improvement Scale (GIS) [ Time Frame: 6 weeks ]GIS assessment after 6-week study treatment by investigator
- Change in the concentration of salivary cortisol [ Time Frame: Baseline and 6 weeks ]
- Change in the concentration of interleukin-6 and interleukin 1b [ Time Frame: Baseline and 6 weeks ]
- Heart Rate Variability (HRV) parameters at resting [ Time Frame: Baseline and 6 weeks ]
- Drug compliance [ Time Frame: 6 weeks ]Compliance rate of used study drugs to prescribed study drugs after 6-week treatment
- Adverse Events [ Time Frame: 9 weeks ]All adverse events reported for study duration of 9 weeks
|Study Start Date:||January 2013|
|Study Completion Date:||September 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks
Other Name: Normal saline solution (NaCl 0.9%)
Experimental: GCJBP Laennec Inj.
GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks
Drug: GCJBP Laennec Inj.
Other Name: Human placenta hydrolysate
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742013
|Korea, Republic of|
|Kangbuk Samsung Hospital|
|Seoul, Korea, Republic of|
|Ajou University Hospital|
|Suwon-si, Korea, Republic of|
|Principal Investigator:||Ho Cheol Shin, M.D., Ph.d.||Kangbuk Samsung Hospital|