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

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

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 Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome; Idiopathic Chronic Fatigue
• Intervention / Treatment: Drug: Placebo; Drug: GCJBP Laennec Inj.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Suwon-si, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ho Cheol Shin, M.D., Ph.D.
• Collaborators: Green Cross Corporation; Ajou University School of Medicine; Symyoo
• Investigators: Principal Investigator: Ho Cheol Shin, M.D., Ph.d., Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: December 2, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): September 26, 2013
• Last Update Submitted That Met QC Criteria: September 24, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: ICF; CFS; Chronic Fatigue; human placenta
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: Laennec-IIT