Chronic Fatigue Syndrome, Idiopathic Chronic Fatigue
Conditions
Keywords
Chronic Fatigue, CFS, ICF, human placenta
Brief summary
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.
Interventions
DRUGGCJBP Laennec Inj.
Test drug
DRUGPlacebo
Comparator
Sponsors
Ajou University School of Medicine
Green Cross Corporation
Symyoo
Ho Cheol Shin, M.D., Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Fatigue Severity Scale (FSS) | Baseline and 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability (HRV) parameters at resting | Baseline and 6 weeks | — |
| Drug compliance | 6 weeks | Compliance rate of used study drugs to prescribed study drugs after 6-week treatment |
| Adverse Events | 9 weeks | All adverse events reported for study duration of 9 weeks |
| Change per item of Fatigue Severity Scale (FSS) | Baseline, 3, 6 and 9 weeks | — |
| Change in the concentration of interleukin-6 and interleukin 1b | Baseline and 6 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 | GIS assessment after 6-week study treatment by investigator |
| Change in the concentration of salivary cortisol | Baseline and 6 weeks | — |
| Rate of patients whose FSS decreased from 4 and more to less than 4 | Baseline, 3, 6 and 9 weeks | — |
Countries
South Korea
Outcome results
None listed