Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01742013
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : September 26, 2013
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

Tracking Information
First Submitted Date  ICMJE November 29, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date September 26, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2012)
Change of Fatigue Severity Scale (FSS) [ Time Frame: Baseline and 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01742013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2012)
  • Change per item of Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 3, 6 and 9 weeks ]
  • Rate of patients whose FSS decreased from 4 and more to less than 4 [ Time Frame: Baseline, 3, 6 and 9 weeks ]
  • Change of Visual Analogue Scale (VAS) [ Time Frame: Baseline, 3 and 6 weeks ]
  • Change of Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 3 and 6 weeks ]
  • Global Improvement Scale (GIS) [ Time Frame: 6 weeks ]
    GIS assessment after 6-week study treatment by investigator
  • Change in the concentration of salivary cortisol [ Time Frame: Baseline and 6 weeks ]
  • Change in the concentration of interleukin-6 and interleukin 1b [ Time Frame: Baseline and 6 weeks ]
  • Heart Rate Variability (HRV) parameters at resting [ Time Frame: Baseline and 6 weeks ]
  • Drug compliance [ Time Frame: 6 weeks ]
    Compliance rate of used study drugs to prescribed study drugs after 6-week treatment
  • Adverse Events [ Time Frame: 9 weeks ]
    All adverse events reported for study duration of 9 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Fatigue Syndrome
  • Idiopathic Chronic Fatigue
Intervention  ICMJE
  • Drug: GCJBP Laennec Inj.
    Test drug
    Other Name: Human placenta hydrolysate
  • Drug: Placebo
    Comparator
    Other Name: Normal saline solution (NaCl 0.9%)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks
    Intervention: Drug: Placebo
  • Experimental: GCJBP Laennec Inj.
    GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks
    Intervention: Drug: GCJBP Laennec Inj.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2012)
78
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01742013
Other Study ID Numbers  ICMJE Laennec-IIT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ho Cheol Shin, M.D., Ph.D., Kangbuk Samsung Hospital
Study Sponsor  ICMJE Ho Cheol Shin, M.D., Ph.D.
Collaborators  ICMJE
  • Ajou University School of Medicine
  • Green Cross Corporation
  • Symyoo
Investigators  ICMJE
Principal Investigator: Ho Cheol Shin, M.D., Ph.d. Kangbuk Samsung Hospital
PRS Account Kangbuk Samsung Hospital
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP