Chronic Fatigue SyndromePhase 3NCT01742013
Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients
A Phase 3 study testing GCJBP Laennec Inj. in people with Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue, run by Ho Cheol Shin, M.D., Ph.D. at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Idiopathic Chronic Fatigue
- What is being tested?
- GCJBP Laennec Inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2013to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kangbuk Samsung Hospital
Seoul
Ajou University Hospital
Suwon
About this study
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
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.
- Being tested
- GCJBP Laennec Inj., Placebo
- Keywords
- Chronic Fatigue, CFS, ICF, human placenta
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCJBP Laennec Inj.Drug
Also called Human placenta hydrolysate
Test drug
PlaceboDrug
Also called Normal saline solution (NaCl 0.9%)
Comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks Receives: Drug: Placebo |
| GCJBP Laennec Inj. | Experimental | GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks Receives: Drug: GCJBP Laennec Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fatigue Severity Scale (FSS)
Measured: Baseline and 6 weeks
Secondary outcomes (10)
Change per item of Fatigue Severity Scale (FSS)
Measured: Baseline, 3, 6 and 9 weeks
Rate of patients whose FSS decreased from 4 and more to less than 4
Measured: Baseline, 3, 6 and 9 weeks
Change of Visual Analogue Scale (VAS)
Measured: Baseline, 3 and 6 weeks
Change of Multidimensional Fatigue Inventory (MFI)
Measured: Baseline, 3 and 6 weeks
Global Improvement Scale (GIS)
GIS assessment after 6-week study treatment by investigator
Measured: 6 weeks
Change in the concentration of salivary cortisol
Measured: Baseline and 6 weeks
Change in the concentration of interleukin-6 and interleukin 1b
Measured: Baseline and 6 weeks
Heart Rate Variability (HRV) parameters at resting
Measured: Baseline and 6 weeks
Drug compliance
Compliance rate of used study drugs to prescribed study drugs after 6-week treatment
Measured: 6 weeks
Adverse Events
All adverse events reported for study duration of 9 weeks
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ho Cheol Shin, M.D., Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Ajou University School of Medicine, Green Cross Corporation, Symyoo
- Responsible party
- Sponsor-investigator, Ho Cheol Shin, M.D., Ph.D., Kangbuk Samsung Hospital
- Investigators
- Ho Cheol Shin, M.D., Ph.d., Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742013
- Sponsor's protocol ID
- Laennec-IIT
- Status last verified
- Sep 2013
- First submitted
- 29 Nov 2012
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01742013
- Acronym / sponsor ID
- Laennec-IIT
- Keywords
- Chronic Fatigue, CFS, ICF, human placenta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ho Cheol Shin, M.D., Ph.D.University, hospital or other
- Collaborators
- Ajou University School of Medicine, Green Cross Corporation, Symyoo
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks |
| GCJBP Laennec Inj. | Experimental | Drug: GCJBP Laennec Inj.GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCJBP Laennec Inj.Also: Human placenta hydrolysateTest drug | Drug | GCJBP Laennec Inj. |
| PlaceboAlso: Normal saline solution (NaCl 0.9%)Comparator | Drug | Placebo |
Primary outcome
Change of Fatigue Severity Scale (FSS)
Time frame: Baseline and 6 weeks
10 secondary outcomes
Change per item of Fatigue Severity Scale (FSS)
Time frame: Baseline, 3, 6 and 9 weeks
Rate of patients whose FSS decreased from 4 and more to less than 4
Time frame: Baseline, 3, 6 and 9 weeks
Change of Visual Analogue Scale (VAS)
Time frame: Baseline, 3 and 6 weeks
Change of Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, 3 and 6 weeks
Global Improvement Scale (GIS)
Time frame: 6 weeks
Change in the concentration of salivary cortisol
Time frame: Baseline and 6 weeks
Change in the concentration of interleukin-6 and interleukin 1b
Time frame: Baseline and 6 weeks
Heart Rate Variability (HRV) parameters at resting
Time frame: Baseline and 6 weeks
Drug compliance
Time frame: 6 weeks
Adverse Events
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Cheol Shin, M.D., Ph.d. principal investigator
Kangbuk Samsung Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GCJBP Laennec Inj. in people with Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue, run by Ho Cheol Shin, M.D., Ph.D. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Fatigue Severity Scale (FSS) (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.