Reported trial results for Chronic Fatigue Syndrome
Every Chronic Fatigue Syndrome trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
11 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT05200858 · results posted 16 July 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05200858) enrolled 30 people in total — 15 in an active treatment group and 15 in a placebo (dummy treatment) group. The trial ran in two back-to-back four-week periods: a blinded phase (where participants did not know which group they were in) and an unblinded phase (where they did know). The main thing the trial was measuring was how much pain interfered with daily functioning, using a standard questionnaire called the Brief Pain Inventory, scored from 0 (no interference) to 10 (complete interference). Secondary measures included pain severity, fatigue, and aspects of walking such as step rate and timing. The reported data shows that during the blinded phase, the active group's pain interference score changed by an average of 0.454 points on the 0–10 scale, compared to 0.198 points in the placebo group. For pain severity (also on a 0–10 scale), the reported average change was 1.184 points in the active group and 0.289 points in the placebo group. Regarding fatigue (measured on a 0–100 scale), the reported change was 2.821 points in the active group and 2.231 points in the placebo group. For the walking measures, the reported data shows the active group took about 1.13 seconds per stride compared to 1.16 seconds in the placebo group, walked at 106.42 steps per minute versus 105.90, and spent about 22.84% of each stride with both feet on the ground compared to 22.64% in the placebo group. Results from the unblinded phase were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT03674541 · results posted 4 October 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people in total — 23 received the study drug pyridostigmine and 22 received a placebo (a dummy treatment with no active ingredient). All 45 participants completed the trial. The trial was investigating how pyridostigmine affected the body's ability to take up and use oxygen during exercise, measured using a specialised exercise test called an invasive cardiopulmonary exercise test (iCPET). This type of testing is relevant to ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome), a condition where patients often perform worse on a second exercise test done shortly after the first. The reported data shows the following for the main outcome — the change in peak oxygen uptake (how much oxygen the body was using at maximum effort) between the first and second exercise tests: the pyridostigmine group showed a small increase of 13.3 mL/min, while the placebo group showed a decrease of 40.3 mL/min in women and an increase of 111.8 mL/min in men. For the secondary outcomes, the reported data shows similar patterns across measures of heart function (cardiac output, measured in litres per minute) and heart pressure (right atrial pressure, measured in mmHg), with the pyridostigmine group generally showing smaller changes between the two exercise tests compared to the female placebo group, though the male placebo group figures were notably higher across several measures. No information about why the placebo results were reported separately by sex was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03853148 · results posted 29 July 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people across four groups. Three groups included older adults trying different combinations of exercise programs: one group did the Otago exercise programme alone (a balance and strength routine), a second group did Otago plus gentle yogic breathing, and a third group added behavioural activation (a structured approach to increasing positive daily activities) on top of both. A fourth group of 20 caregivers did gentle yoga and yogic breathing. The trial measured changes in pain intensity, pain-related behaviours, fatigue, physical function, and balance. It is worth noting that a notable number of participants did not complete the study — roughly half of the older adult participants in each group, and five of the 20 caregivers. The reported data shows changes in scores on standardised questionnaires (called T-scores), where the starting point of 50 represents the average for the general population, and higher scores mean more of the thing being measured (such as more pain or more fatigue). For pain intensity, the three older adult groups showed average score changes of −3.25, −2.8, and −0.5 respectively, meaning scores moved downward from where they started. For fatigue, the reported changes were +0.9, −0.8, and −4.0 across the three groups. For pain-related behaviours, the changes were −0.7, +2.2, and −3.7. On physical function (where higher scores are better), all four groups showed small increases of between 1.0 and 3.1 points. For balance (scored out of 56), the three older adult groups showed average changes of −1.8, −4.5, and −4.5. The sit-to-stand test data was not reported, as the trial team noted that COVID-19 restrictions prevented them from collecting those measurements in person. The caregiver group's results were not reported for the pain and balance measures in the data submitted. No figures were provided comparing groups against each other in a formal way, so the reported data shows only the average change within each group from the beginning to the end of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01318356 · results posted 23 June 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 155 people across three groups: 51 received Cognitive Behavioural Therapy (CBT), 52 received an antibiotic called doxycycline, and 52 received a placebo (a dummy treatment with no active ingredient). The trial was measuring fatigue severity and its impact on daily life in people who were experiencing significant fatigue. By the end of the study, 43 people in the CBT group, 49 in the doxycycline group, and 50 in the placebo group had completed the trial. The reported data shows that fatigue was measured using a questionnaire called the Checklist Individual Strength, scored from 8 to 56, where higher numbers mean more severe fatigue and a score of 35 or above is considered severely fatigued. At the end of the study, the CBT group recorded an average score of 31.6, the doxycycline group recorded 40.8, and the placebo group recorded 37.8. Two further questionnaires were also reported. One measured how much fatigue was disrupting everyday activities (scored 0 to 5,799, higher meaning more disruption, with 450 or above considered significantly disabling): the CBT group averaged 786.8, the doxycycline group averaged 1,101.5, and the placebo group averaged 963.8. The other measured psychological distress (scored 90 to 450, lower meaning better wellbeing): the CBT group averaged 127.1, the doxycycline group averaged 149.2, and the placebo group averaged 142.6. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02055898 · results posted 18 November 2020
According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning participants tried both treatments at different times — involving 13 people in total (7 in one group, 6 in the other). The trial was looking at two main things: brain wave activity during sleep (specifically a type of slow electrical activity measured by a brain scan called an EEG) and daytime sleepiness (measured by how quickly participants fell asleep during a daytime test). One treatment was sodium oxybate, a medication, and the other was a placebo (a dummy treatment with no active ingredient). There was a "washout" break of at least 14 days between the two treatments to let any effects wear off before swapping over. Ten participants completed both treatment periods. The reported data shows the following numbers. For brain wave activity during sleep (measured in units called uV²/Hz — simply a way of quantifying electrical signals), two sets of measurements were recorded: in the first set, the sodium oxybate group returned a value of approximately 0.0000265 compared with 0.0000226 for the placebo group; in the second set, the sodium oxybate group recorded approximately 0.0000305 compared with 0.0000176 for the placebo group. For daytime sleepiness, participants were tested on how many minutes it took them to fall asleep during the day. In the first set of measurements, the sodium oxybate group took an average of about 17.0 minutes to fall asleep, compared with about 15.3 minutes for the placebo group. In the second set, the sodium oxybate group averaged about 17.9 minutes, compared with about 17.2 minutes for the placebo group. It is worth noting that this was a very small trial, and the reported data does not include information about the level of certainty around these figures (such as margins of error), so the numbers should be understood as a summary of what was observed in this particular group of participants only. No reasons were reported for why three participants did not complete the first treatment period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02530515 · results posted 29 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02530515) enrolled 8 participants, all of whom were placed in Arm C. Arms A and B had no participants enrolled. The trial was looking at whether it was possible to give patients with chronic lymphocytic leukaemia (a type of blood cancer) an infusion of their own specially prepared immune cells called activated T-cells, and whether this could be done without causing serious side effects (called dose-limiting toxicities, or DLTs — meaning severe reactions judged to be caused by the T-cell treatment). The reported data shows that, of the 8 participants who started the study, all 8 completed it. For the main (primary) outcome, the results indicate that 7 out of 8 participants received the target dose of activated T-cells without experiencing a dose-limiting toxicity. The trial's pre-set benchmark for feasibility was that more than half of enrolled patients would need to achieve this target dose without serious side effects — the reported data shows this benchmark was met. For the secondary outcomes — which looked at immune system recovery after the infusion, overall response rates, and rates of infection over up to one year — no numerical results were reported in the data submitted to ClinicalTrials.gov. These findings are therefore not available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00598585 · results posted 27 June 2017
According to the results reported on ClinicalTrials.gov, this trial looked at whether sildenafil (compared to a placebo, or dummy pill) had any effect on fatigue in a small group of participants. A total of 12 people took part — 6 in the sildenafil group and 6 in the placebo group. By the end of the study, 5 people in the sildenafil group and all 6 in the placebo group had completed the trial; one person in the sildenafil group did not finish. The main thing being measured was a change in something called the Fatigue Impact Scale — a questionnaire with 42 questions where people rate how much fatigue affects their daily life. Scores can range from 0 (no impact at all) to 148 (the most severe impact). The reported data shows that, after 6 weeks, the sildenafil group's average score went down by 32.6 points, while the placebo group's average score went down by 1.5 points. A lower score means less reported impact from fatigue. No secondary outcome data was reported in the submitted results. It is worth noting that this was a very small trial — just 12 people in total — which means these numbers should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT00810368 · results posted 18 August 2016
According to the results reported on ClinicalTrials.gov, this trial looked at whether a supplement called carnosine had any effect on people with Chronic Fatigue Syndrome (CFS). A total of 33 people were enrolled — 18 in the carnosine group and 15 in a placebo (dummy treatment) group. By the end of the 12-week study, 12 people in the carnosine group and 13 in the placebo group had completed it. The trial measured several things, including overall CFS symptom severity, fatigue levels, bodily pain, anxiety, diarrhoea symptoms, and a thinking/speed task. The reported data shows the following numbers at the end of 12 weeks. On the overall CFS symptom severity score (which runs from 0 to 36, where lower is better), the carnosine group's average score changed by −3.8 points from the start, while the placebo group's changed by −2.0 points. On the fatigue score (0–10 scale), the carnosine group's average changed by +0.3 (a slight increase) compared to −0.6 for the placebo group. For bodily pain (scored 0–100, where higher means less pain), the carnosine group's average score changed by +5.6 points, while the placebo group's changed by −0.5 points. On the anxiety scale (0–28, lower is better), the carnosine group changed by +0.2 and the placebo group by −0.9. Five participants in the carnosine group reported improved diarrhoea symptoms, compared to one in the placebo group. On the thinking/speed task, the carnosine group's average score improved by 10.8 points versus 2.7 points for the placebo group. It is worth noting that the trial was relatively small, and a number of participants — particularly in the carnosine group — did not complete the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00498485 · results posted 21 April 2016
According to the results reported on ClinicalTrials.gov, this trial compared a medication called Xyrem against a placebo (a dummy treatment with no active ingredient) in a small group of participants. A total of 17 people took part — 7 in the placebo group and 10 in the Xyrem group. The trial was measuring two things: how participants felt their overall condition had changed during the study, and how they rated the quality of their sleep over the past week. The reported data shows that for the first measure — the "Global Assessment of Change" — participants were asked to rate whether they felt much better, the same, or much worse, on a scale from +2 (much better) to -2 (much worse). Six participants from the placebo group and five from the Xyrem group provided responses that were counted for this outcome. It is worth noting that not everyone who started the trial finished it — 1 person in the placebo group and 5 people in the Xyrem group did not complete the study, though the reasons were not detailed in the data provided here. For the second measure — self-reported sleep quality — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00252629 · results posted 11 December 2014
According to the results reported on ClinicalTrials.gov, this trial involved 29 participants in total across three groups. Nine people received therapeutic nasal CPAP (a device that delivers steady air pressure during sleep), nine received a sham (inactive) version of the same device, and eleven were healthy comparison participants. The trial was looking at two main things: whether a particular breathing pattern during sleep — called inspiratory flow limitation (IFL), where airflow becomes restricted during breathing in — was more common in veterans with Gulf War Syndrome (GWS) compared to veterans without symptoms, and whether three weeks of CPAP treatment changed fatigue levels in the GWS group. The reported data shows that, among veterans with GWS, approximately 96% of sampled breaths during sleep showed this flow-limited pattern, compared to around 36% in the asymptomatic (symptom-free) veterans. For the treatment comparison, fatigue scores — measured on a 1-to-7 scale where higher numbers mean greater fatigue — changed by an average of 2.1 points in the therapeutic CPAP group and 0.2 points in the sham CPAP group. Pain scores (on a 0–10 scale) changed by 2.0 points in the therapeutic group versus 0.4 in the sham group. Scores for cognitive difficulties such as memory and concentration (also on a 0–10 scale) changed by 2.0 points in the therapeutic group and 0.4 in the sham group. It is worth noting that one participant in the therapeutic CPAP group did not complete the study, and the data does not report a reason. The reported data shows changes from before to after treatment, but the direction of those changes (whether scores went up or down) was not explicitly stated in the submitted results data, so this detail cannot be confirmed here. No safety or tolerability data was reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00506454 · results posted 15 August 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00506454) involved 22 people in total — 11 in the active treatment group and 11 in the placebo group. One person from each group did not complete the study, leaving 10 in each group who finished. The trial was measuring something called endotoxin levels — endotoxins are substances that can be released by bacteria and found in the bloodstream. Specifically, the trial looked at whether these levels went down after a session of haemodialysis (a kidney filtering treatment) in people receiving the active treatment compared to those receiving a placebo (an inactive substitute). The reported data shows that for the primary outcome — the number of participants whose endotoxin level after haemodialysis was lower than before — 5 out of the treatment group and 5 out of the placebo group showed this reduction. In other words, the same number of people in each group had a drop in their endotoxin levels. No additional outcome measures were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.