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

Sponsor

Ho Cheol Shin, M.D., Ph.D. (Other)

Overall Status

Completed

CT.gov ID

NCT01742013

Collaborator

Ajou University School of Medicine (Other), Green Cross Corporation (Industry), Symyoo (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome Idiopathic Chronic Fatigue	Drug: GCJBP Laennec Inj. Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks	Drug: Placebo Comparator Other Names: Normal saline solution (NaCl 0.9%)
Experimental: GCJBP Laennec Inj. GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks	Drug: GCJBP Laennec Inj. Test drug Other Names: Human placenta hydrolysate

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Drug: Placebo

Comparator

Other Names:

Normal saline solution (NaCl 0.9%)

Experimental: GCJBP Laennec Inj.

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

Drug: GCJBP Laennec Inj.

Test drug

Other Names:

Human placenta hydrolysate

Outcome Measures

Primary Outcome Measures

Change of Fatigue Severity Scale (FSS) [Baseline and 6 weeks]

Secondary Outcome Measures

Change per item of Fatigue Severity Scale (FSS) [Baseline, 3, 6 and 9 weeks]
Rate of patients whose FSS decreased from 4 and more to less than 4 [Baseline, 3, 6 and 9 weeks]
Change of Visual Analogue Scale (VAS) [Baseline, 3 and 6 weeks]
Change of Multidimensional Fatigue Inventory (MFI) [Baseline, 3 and 6 weeks]
Global Improvement Scale (GIS) [6 weeks]
GIS assessment after 6-week study treatment by investigator
Change in the concentration of salivary cortisol [Baseline and 6 weeks]
Change in the concentration of interleukin-6 and interleukin 1b [Baseline and 6 weeks]
Heart Rate Variability (HRV) parameters at resting [Baseline and 6 weeks]
Drug compliance [6 weeks]
Compliance rate of used study drugs to prescribed study drugs after 6-week treatment
Adverse Events [9 weeks]
All adverse events reported for study duration of 9 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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