NCT01742013

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Ho Cheol Shin, M.D., Ph.D. · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Fatigue Syndrome
• Idiopathic Chronic Fatigue

Interventions

Type	Name	Description
DRUG	GCJBP Laennec Inj.	Test drug
DRUG	Placebo	Comparator

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-12-05
• Last updated: 2013-09-26

Locations

2 sites across 1 country: South Korea