Chronic Fatigue Syndrome Clinical Trial
Official title:
Assessing Patient Engagement and Understanding in Chronic Fatigue Syndrome Clinical Trials
| NCT number | NCT05967494 |
| Other study ID # | 84606875 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2024 |
| Est. completion date | August 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | August 2026 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Signed Written Informed Consent - Aged = 18 years old - No prior treatment for chronic fatigue syndrome Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
Galeoto 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. — View Citation
Kim 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. Erratum In: J Transl Med. 2020 Dec 23;18(1):492. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patients who decide to join in a chronic fatigue syndrome clinical trial | 3 months | ||
| Primary | Number of chronic fatigue syndrome patients who remain in clinical trial until completion | 12 months |
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