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

Last updated: September 24, 2013
Sponsor: Ho Cheol Shin, M.D., Ph.D.
Overall Status: Completed

Phase

3

Condition

Chronic Fatigue Syndrome

Fibromyalgia

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01742013
Laennec-IIT
  • Ages 20-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 6weeks

Exclusion

Exclusion Criteria:

  • Patient who has been administrated with any other investigational product for 28 daysprior to screening visit

  • Patient who is pregnant or childbearing potential female patient who does not consentfor contraception during the study

  • Patient who has a hypersensitivity provoked by study drug or others drived fromanimals

  • Patient who has been received with any human placenta product for 6 months beforestudy 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 toparticipate in the study

Study Design

Total Participants: 78
Study Start date:
January 01, 2013
Estimated Completion Date:
September 30, 2013

Connect with a study center

  • Kangbuk Samsung Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon-si,
    Korea, Republic of

    Site Not Available

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