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

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

Status and phase: Completed; Phase 3

Conditions: Idiopathic Chronic Fatigue; Chronic Fatigue Syndrome

Treatments: Drug: GCJBP Laennec Inj.; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01742013

Laennec-IIT

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks

Treatment:

Drug: Placebo

GCJBP Laennec Inj.

Experimental group

Description:

GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks

Treatment:

Drug: GCJBP Laennec Inj.