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

• ClinicalTrials.gov Identifier: NCT01742013
• Recruitment Status: Completed
• First Posted: December 5, 2012
• Last Update Posted: September 26, 2013
• Sponsor: Ho Cheol Shin, M.D., Ph.D.
• 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: November 29, 2012
• First Posted Date: December 5, 2012
• Last Update Posted Date: September 26, 2013
• Study Start Date: January 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 2, 2012): Change of Fatigue Severity Scale (FSS) [ Time Frame: Baseline and 6 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Chronic Fatigue Syndrome
• Idiopathic Chronic Fatigue

Intervention

• Drug: GCJBP Laennec Inj.
  Test drug
  Other Name: Human placenta hydrolysate
• Drug: Placebo
  Comparator
  Other Name: Normal saline solution (NaCl 0.9%)

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2012): 78
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01742013
• Other Study ID Numbers: Laennec-IIT
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ho Cheol Shin, M.D., Ph.D., Kangbuk Samsung Hospital
• Study Sponsor: Ho Cheol Shin, M.D., Ph.D.

Collaborators

• Ajou University School of Medicine
• Green Cross Corporation
• Symyoo

Investigators

• Principal Investigator: Ho Cheol Shin, M.D., Ph.d.; Kangbuk Samsung Hospital

• PRS Account: Kangbuk Samsung Hospital
• Verification Date: September 2013