Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ajou University School of Medicine | OTHER |
| Green Cross Corporation | INDUSTRY |
| Symyoo | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks |
|
| GCJBP Laennec Inj. | Experimental | GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCJBP Laennec Inj. | Drug | Test drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fatigue Severity Scale (FSS) | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ho Cheol Shin, M.D., Ph.d. | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | South Korea | ||||
| Ajou University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Comparator |
|
|
| 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) | GIS assessment after 6-week study treatment by investigator | 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 | Compliance rate of used study drugs to prescribed study drugs after 6-week treatment | 6 weeks |
| Adverse Events | All adverse events reported for study duration of 9 weeks | 9 weeks |
| Suwon |
| South Korea |
| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided