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NCT Number: NCT01742013

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

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.

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Idiopathic Chronic Fatigue Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kangbuk Samsung Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GCJBP Laennec Inj.

Drug

Test drug

Other names: Human placenta hydrolysate

Placebo

Drug

Comparator

Other names: Normal saline solution (NaCl 0.9%)

Primary outcomes

  1. Change of Fatigue Severity Scale (FSS)

    Time frame: Baseline and 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ho Cheol Shin, M.D., Ph.D.

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Sep 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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