Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate...
Chronic Fatigue SyndromeIdiopathic Chronic FatigueGCJBP 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.
The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention...
Chronic Fatigue SyndromeThis study aims to improve on the delivery of treatment for people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). People with CFS/ME have low energy. This interferes with doing everyday activities and has a major impact on quality of life. Energy management is a key aspect of treatment and involves patients building up their energy levels gradually. Their health professional finds out how much energy the patient uses daily so they can prescribe how much activity and rest is right for the patient. The prescription is adjusted throughout treatment. Over time, the patient learns the best way to "spend" and "preserve" energy. To begin treatment, patients record their activity levels on paper over a few weeks. Records need to be accurate, but this is often difficult because of problems with memory, concentration or low energy and pain. We have recently developed a new technology called ASARM ("Advanced Sleep Rest Activity and Rest Management") that records activity levels electronically and checks whether they match the activity prescription. The ASARM device is worn on the patient's wrist. It measures sleep, activity and rest, and has an electronic diary (a smartphone app) for recording daily activities. The health professional has remote access to the information and uses the app to change the prescription. This study will investigate if ASARM is (i) acceptable to patients; (ii) a good way to deliver Cognitive Behavioural therapy CBT treatment; (iii) able to improve their symptoms. Patients and clinicians will gain experience of ASARM for a short time, and we will analyse their data. Our findings will help us develop ASARM so that it can be used in routine care of CFS/ME patients.
Cytokine Inhibition in Chronic Fatigue Syndrome Patients
Chronic Fatigue SyndromeRationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. Although derangements of the cytokine network in CFS are controversial, a major problem is that many studies did not use adequate controls. In addition, all studies have been performed on peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the brain, the information that can be derived from peripheral blood cells is limited. The only information regarding the possible role of cytokines in the pathophysiology of CFS could come from intervention studies in which pathogenetically important cytokines are inhibited. A potentially relevant cytokine which can be blocked in humans without severe side effects is IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited evidence for this. Objective: To investigate the effect on symptomatology of interference with IL-1 in CFS patients. Study design: A randomized placebo controlled study will be performed to determine whether interference with IL-1 is able to reduce fatigue and disabilities in CFS patients. Study population: Female CFS patients without psychiatric co-morbidity will be included in this study. Patients of the outpatient clinic of the Department of General internal medicine and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study. Patients will be asked to bring a healthy neighbourhood control to their first study visit. Intervention: After inclusion patients will be randomized to receive one of the following treatments: interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25); placebo for 4 weeks (N=25). Main study parameters/endpoints: The primary outcome measure will be fatigue severity measured with the Checklist Individual Strength (CIS) at 4 weeks, measurement will be repeated up to 26 weeks. Secondary outcome measures will be: level of functional impairment measured with the Sickness Impact Profile (SIP8) total score; physical and social functioning assessed with the subscale physical functioning and social functioning of the SF-36; level of psychological distress assessed with the total score on the Symptom Checklist-90 (SCL-90); pain severity assessed with a Visual Analog Scale (VAS); cytokine measurement in blood (plasma and blood in Pax-gene tubes) and saliva (at protein and mRNA level); cortisol measurement in saliva and hair; microbiome determination in faeces; body temperature and pulse rate.
Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome
Chronic Fatigue SyndromeGiven the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS.
Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)...
Fatigue SyndromeChronic1 moreThe purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention...
Chronic Fatigue SyndromeMyalgic EncephalomyelitisThe purpose of this study IS to explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in adolescent CFS.
Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
FibromyalgiaChronic Fatigue SyndromeTo determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).
Valganciclovir (Valcyte) for Chronic Fatigue Syndrome Patients Who Have Elevated Antibody Titers...
Chronic Fatigue SyndromeThe purpose of this study determine whether the drug valganciclovir has a significant and real benefit on the central core of symptoms experienced by patients who have high titers to EBV and HHV-6 and are experiencing long-standing fatigue and cognitive impairment (CFS). In addition, to characterize a quantifiable biological marker in these patients that will facilitate the identification of those likely to respond to valganciclovir and will make it possible to assess response to treatment.
Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome
Fatigue SyndromeChronicThe purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).
Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue...
Myalgic EncephalomyelitisChronic Fatigue SyndromeThis study seeks to investigate the safety, tolerability and efficacy of CT38, an experimental peptide administered by subcutaneous infusion, in the treatment of ME/CFS patients.