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

NCT01742013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2013-09-26

No results posted yet for this study

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

DRUG

GCJBP Laennec Inj.

Test drug

DRUG

Placebo

Comparator

Sponsors & Collaborators

  • Ajou University School of Medicine

    collaborator OTHER

  • Green Cross Corporation

    collaborator INDUSTRY

  • Symyoo

    collaborator INDUSTRY

  • Ho Cheol Shin, M.D., Ph.D.

    lead OTHER

Principal Investigators

  • Ho Cheol Shin, M.D., Ph.d. · Kangbuk Samsung Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01742013 on ClinicalTrials.gov