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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
Test drug
Comparator
Kangbuk Samsung Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
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)
GIS assessment after 6-week study treatment by investigator
Time frame: 6 weeks
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
Compliance rate of used study drugs to prescribed study drugs after 6-week treatment
Time frame: 6 weeks
Adverse Events
All adverse events reported for study duration of 9 weeks
Time frame: 9 weeks
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