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

Primary Purpose

Chronic Fatigue Syndrome, Idiopathic Chronic Fatigue

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GCJBP Laennec Inj.

Placebo

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic Fatigue, CFS, ICF, human placenta

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kangbuk Samsung Hospital
Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

GCJBP Laennec Inj.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of Fatigue Severity Scale (FSS)

Secondary Outcome Measures

Change per item of Fatigue Severity Scale (FSS)

Rate of patients whose FSS decreased from 4 and more to less than 4

Change of Visual Analogue Scale (VAS)

Change of Multidimensional Fatigue Inventory (MFI)

Global Improvement Scale (GIS)

GIS assessment after 6-week study treatment by investigator

Change in the concentration of salivary cortisol

Change in the concentration of interleukin-6 and interleukin 1b

Heart Rate Variability (HRV) parameters at resting

Drug compliance

Compliance rate of used study drugs to prescribed study drugs after 6-week treatment

Adverse Events

All adverse events reported for study duration of 9 weeks

Full Information

NCT ID

NCT01742013

First Posted

November 29, 2012

Last Updated

September 24, 2013

Sponsor

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

Collaborators

Ajou University School of Medicine, Green Cross Corporation, Symyoo

1. Study Identification

Unique Protocol Identification Number

NCT01742013

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

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

Collaborators

Ajou University School of Medicine, Green Cross Corporation, Symyoo

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Fatigue Syndrome, Idiopathic Chronic Fatigue

Keywords

Chronic Fatigue, CFS, ICF, human placenta

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

GCJBP Laennec Inj.

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GCJBP Laennec Inj.

Other Intervention Name(s)

Human placenta hydrolysate

Intervention Description

Test drug

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal saline solution (NaCl 0.9%)

Intervention Description

Comparator

Primary Outcome Measure Information:

Title

Change of Fatigue Severity Scale (FSS)

Time Frame

Baseline and 6 weeks

Secondary Outcome Measure Information:

Title

Change per item of Fatigue Severity Scale (FSS)

Time Frame

Baseline, 3, 6 and 9 weeks

Title

Rate of patients whose FSS decreased from 4 and more to less than 4

Time Frame

Baseline, 3, 6 and 9 weeks

Title

Change of Visual Analogue Scale (VAS)

Time Frame

Baseline, 3 and 6 weeks

Title

Change of Multidimensional Fatigue Inventory (MFI)

Time Frame

Baseline, 3 and 6 weeks

Title

Global Improvement Scale (GIS)

Description

GIS assessment after 6-week study treatment by investigator

Time Frame

6 weeks

Title

Change in the concentration of salivary cortisol

Time Frame

Baseline and 6 weeks

Title

Change in the concentration of interleukin-6 and interleukin 1b

Time Frame

Baseline and 6 weeks

Title

Heart Rate Variability (HRV) parameters at resting

Time Frame

Baseline and 6 weeks

Title

Drug compliance

Description

Compliance rate of used study drugs to prescribed study drugs after 6-week treatment

Time Frame

6 weeks

Title

Adverse Events

Description

All adverse events reported for study duration of 9 weeks

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Kangbuk Samsung Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kangbuk Samsung Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon-si

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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