NCT04007705 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Shivappa N, Steck SE, Hurley TG, Hussey JR, Hébert JR
Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
Silva AR, Bernardo A, Costa J, Cardoso A, Santos P, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrão P
Dietary interventions in fibromyalgia: a systematic review. Ann Med. 2019;51(sup1):2-14. doi: 10.1080/07853890.2018.1564360.
Statovci D, Aguilera M, MacSharry J, Melgar S
The Impact of Western Diet and Nutrients on the Microbiota and Immune Response at Mucosal Interfaces. Front Immunol. 2017 Jul 28;8:838. doi: 10.3389/fimmu.2017.00838. eCollection 2017. Review.
Uçeyler N, Häuser W, Sommer C
Systematic review with meta-analysis: cytokines in fibromyalgia syndrome. BMC Musculoskelet Disord. 2011 Oct 28;12:245. doi: 10.1186/1471-2474-12-245. Review.

Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia

Details for clinical trial NCT04007705

Clinical trial NCT04007705 - References