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

This study has been completed.
Sponsor:
Collaborators:
Ajou University School of Medicine
Green Cross Corporation
Symyoo
Information provided by (Responsible Party):
Ho Cheol Shin, M.D., Ph.D., Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT01742013
First received: November 29, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Chronic Fatigue Syndrome
Idiopathic Chronic Fatigue
Drug: GCJBP Laennec Inj.
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kangbuk Samsung Hospital:

Primary Outcome Measures:
  • Change of Fatigue Severity Scale (FSS) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change per item of Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 3, 6 and 9 weeks ] [ Designated as safety issue: No ]
  • Rate of patients whose FSS decreased from 4 and more to less than 4 [ Time Frame: Baseline, 3, 6 and 9 weeks ] [ Designated as safety issue: No ]
  • Change of Visual Analogue Scale (VAS) [ Time Frame: Baseline, 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Change of Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Global Improvement Scale (GIS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    GIS assessment after 6-week study treatment by investigator

  • Change in the concentration of salivary cortisol [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change in the concentration of interleukin-6 and interleukin 1b [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Heart Rate Variability (HRV) parameters at resting [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Drug compliance [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Compliance rate of used study drugs to prescribed study drugs after 6-week treatment

  • Adverse Events [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
    All adverse events reported for study duration of 9 weeks


Enrollment: 78
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks
Drug: Placebo
Comparator
Other Name: 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 Name: Human placenta hydrolysate

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742013

Locations
Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon-si, Korea, Republic of
Sponsors and Collaborators
Ho Cheol Shin, M.D., Ph.D.
Ajou University School of Medicine
Green Cross Corporation
Symyoo
Investigators
Principal Investigator: Ho Cheol Shin, M.D., Ph.d. Kangbuk Samsung Hospital
  More Information

No publications provided

Responsible Party: Ho Cheol Shin, M.D., Ph.D., Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT01742013     History of Changes
Other Study ID Numbers: Laennec-IIT
Study First Received: November 29, 2012
Last Updated: September 24, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kangbuk Samsung Hospital:
Chronic Fatigue
CFS
ICF
human placenta

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Syndrome
Central Nervous System Diseases
Disease
Encephalomyelitis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014