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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ho Cheol Shin, M.D., Ph.D.
• Collaborators: Ajou University School of Medicine; Green Cross Corporation; Symyoo

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