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

Chronic Fatigue Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742013
• Other study ID #: Laennec-IIT
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2012
• Last updated: September 24, 2013
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Idiopathic Chronic Fatigue

Intervention

Drug:
• GCJBP Laennec Inj.
Test drug
• Placebo
Comparator

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon-si

Sponsors (4)

Lead Sponsor	Collaborator
Ho Cheol Shin, M.D., Ph.D.	Ajou University School of Medicine, Green Cross Corporation, Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Fatigue Severity Scale (FSS)		Baseline and 6 weeks	No
Secondary	Change per item of Fatigue Severity Scale (FSS)		Baseline, 3, 6 and 9 weeks	No
Secondary	Rate of patients whose FSS decreased from 4 and more to less than 4		Baseline, 3, 6 and 9 weeks	No
Secondary	Change of Visual Analogue Scale (VAS)		Baseline, 3 and 6 weeks	No
Secondary	Change of Multidimensional Fatigue Inventory (MFI)		Baseline, 3 and 6 weeks	No
Secondary	Global Improvement Scale (GIS)	GIS assessment after 6-week study treatment by investigator	6 weeks	No
Secondary	Change in the concentration of salivary cortisol		Baseline and 6 weeks	No
Secondary	Change in the concentration of interleukin-6 and interleukin 1b		Baseline and 6 weeks	No
Secondary	Heart Rate Variability (HRV) parameters at resting		Baseline and 6 weeks	No
Secondary	Drug compliance	Compliance rate of used study drugs to prescribed study drugs after 6-week treatment	6 weeks	Yes
Secondary	Adverse Events	All adverse events reported for study duration of 9 weeks	9 weeks	Yes