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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Idiopathic Chronic Fatigue Drug: GCJBP Laennec Inj. Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Change of Fatigue Severity Scale (FSS) [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures :
  1. Change per item of Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 3, 6 and 9 weeks ]
  2. Rate of patients whose FSS decreased from 4 and more to less than 4 [ Time Frame: Baseline, 3, 6 and 9 weeks ]
  3. Change of Visual Analogue Scale (VAS) [ Time Frame: Baseline, 3 and 6 weeks ]
  4. Change of Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 3 and 6 weeks ]
  5. Global Improvement Scale (GIS) [ Time Frame: 6 weeks ]
    GIS assessment after 6-week study treatment by investigator

  6. Change in the concentration of salivary cortisol [ Time Frame: Baseline and 6 weeks ]
  7. Change in the concentration of interleukin-6 and interleukin 1b [ Time Frame: Baseline and 6 weeks ]
  8. Heart Rate Variability (HRV) parameters at resting [ Time Frame: Baseline and 6 weeks ]
  9. Drug compliance [ Time Frame: 6 weeks ]
    Compliance rate of used study drugs to prescribed study drugs after 6-week treatment

  10. Adverse Events [ Time Frame: 9 weeks ]
    All adverse events reported for study duration of 9 weeks


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742013


Locations
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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
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Principal Investigator: Ho Cheol Shin, M.D., Ph.d. Kangbuk Samsung Hospital
More Information
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Responsible Party: Ho Cheol Shin, M.D., Ph.D., Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT01742013    
Other Study ID Numbers: Laennec-IIT
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013
Keywords provided by Ho Cheol Shin, M.D., Ph.D., Kangbuk Samsung Hospital:
Chronic Fatigue
CFS
ICF
human placenta
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Virus Diseases
 Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases