Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Fatigue Syndrome, Idiopathic Chronic Fatigue

Intervention / Treatment
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* Drug: GCJBP Laennec Inj.
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks | Drug: Placebo<br>* Comparator<br>* Other names: Normal saline solution (NaCl 0.9%);|
| Experimental: GCJBP Laennec Inj.<br>GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks | Drug: GCJBP Laennec Inj.<br>* Test drug<br>* Other names: Human placenta hydrolysate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fatigue Severity Scale (FSS) |  | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Fatigue, CFS, ICF, human placenta