Clinical trial NCT01742013: Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Fatigue Syndrome
Idiopathic Chronic Fatigue
Keywords: Chronic Fatigue
CFS
ICF
human placenta
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
name: Green Cross Corporation
name: Symyoo
First posted: 2012-12-05
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Fatigue Severity Scale (FSS)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change per item of Fatigue Severity Scale (FSS)
timeFrame: Baseline, 3, 6 and 9 weeks
measure: Rate of patients whose FSS decreased from 4 and more to less than 4
timeFrame: Baseline, 3, 6 and 9 weeks
measure: Change of Visual Analogue Scale (VAS)
timeFrame: Baseline, 3 and 6 weeks
measure: Change of Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, 3 and 6 weeks
measure: Global Improvement Scale (GIS)
timeFrame: 6 weeks
measure: Change in the concentration of salivary cortisol
timeFrame: Baseline and 6 weeks
measure: Change in the concentration of interleukin-6 and interleukin 1b
timeFrame: Baseline and 6 weeks
measure: Heart Rate Variability (HRV) parameters at resting
timeFrame: Baseline and 6 weeks
measure: Drug compliance
timeFrame: 6 weeks
measure: Adverse Events
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Ho Cheol Shin, M.D., Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: