Chronic Fatigue SyndromeNCT05967494
Discovering Trends in Chronic Fatigue Syndrome Patients' Clinical Study Experiences
An observational study of Chronic Fatigue Syndrome, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Aug 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic fatigue syndrome who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.
Who may be able to join
- Signed Written Informed Consent
- Aged ≥ 18 years old
- No prior treatment for chronic fatigue syndrome
Who cannot join
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
- Women of childbearing potential without a negative pregnancy test; or women who are lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Assessing Patient Engagement and Understanding in Chronic Fatigue Syndrome Clinical Trials
The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.
The data collected from this study will help improve future outcomes for all chronic fatigue syndrome patients as well as those in under-represented demographic groups.
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome
- Medical subject headings
- Fatigue Syndrome, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to join in a chronic fatigue syndrome clinical trial
Measured: 3 months
Number of chronic fatigue syndrome patients who remain in clinical trial until completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967494
- Sponsor's protocol ID
- 84606875
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meng XD, Guo HR, Zhang QY, Li X, Chen Y, Li MY, Zhuo XM, Wang MJ, Shan K, Gong YN, Li NC, Chen B, Chen ZL, Guo Y. The effectiveness of cupping therapy on chronic fatigue syndrome: A single-blind randomized controlled trial. Complement Ther Clin Pract. 2020 Aug;40:101210. doi: 10.1016/j.ctcp.2020.101210. Epub 2020 Jun 20.
PubMed 32891286Kim DY, Lee JS, Park SY, Kim SJ, Son CG. Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). J Transl Med. 2020 Jan 6;18(1):7. doi: 10.1186/s12967-019-02196-9.
PubMed 31906979Galeoto G, Sansoni J, Valenti D, Mollica R, Valente D, Parente M, Servadio A. The effect of physiotherapy on fatigue and physical functioning in chronic fatigue syndrome patients: A systematic review. Clin Ter. 2018 Jul-Aug;169(4):e184-e188. doi: 10.7417/T.2018.2076.
PubMed 30151552
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Engagement and Understanding in Chronic Fatigue Syndrome Clinical Trials
- ClinicalTrials.gov ID
- NCT05967494
- Acronym / sponsor ID
- 84606875
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- 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.
The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.
The data collected from this study will help improve future outcomes for all chronic fatigue syndrome patients as well as those in under-represented demographic groups.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic fatigue syndrome who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Signed Written Informed Consent
- Aged ≥ 18 years old
- No prior treatment for chronic fatigue syndrome
Key exclusion criteria (3 listed)
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
- Women of childbearing potential without a negative pregnancy test; or women who are lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients who decide to join in a chronic fatigue syndrome clinical trial
Time frame: 3 months
Number of chronic fatigue syndrome patients who remain in clinical trial until completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 32891286Meng XD, Guo HR, Zhang QY, Li X, Chen Y, Li MY, Zhuo XM, Wang MJ, Shan K, Gong YN, Li NC, Chen B, Chen ZL, Guo Y. The effectiveness of cupping therapy on chronic fatigue syndrome: A single-blind randomized controlled trial. Complement Ther Clin Pract. 2020 Aug;40:101210. doi: 10.1016/j.ctcp.2020.101210. Epub 2020 Jun 20.
- Background: PubMed 31906979Kim DY, Lee JS, Park SY, Kim SJ, Son CG. Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). J Transl Med. 2020 Jan 6;18(1):7. doi: 10.1186/s12967-019-02196-9.
- Background: PubMed 30151552Galeoto G, Sansoni J, Valenti D, Mollica R, Valente D, Parente M, Servadio A. The effect of physiotherapy on fatigue and physical functioning in chronic fatigue syndrome patients: A systematic review. Clin Ter. 2018 Jul-Aug;169(4):e184-e188. doi: 10.7417/T.2018.2076.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by Power Life Sciences Inc. at 1 site in United States.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill ((415) 900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to join in a chronic fatigue syndrome clinical trial (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967494, which also lists 3 linked publications.
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 1 Aug 2023.