NCT03911882

Efficacy and Tolerability of CELERGEN in Fibromyalgia

Completed Last updated 16 April 2019

What this trial tests

trial testing Celergen Administration in Fibromyalgia in 90 participants. Completed in 30 August 2016.

Timeline

29 April 2016

Primary endpoint
29 July 2016

30 August 2016

Quick facts

Lead sponsor	Celergan SA
Status	Completed
Study type	OBSERVATIONAL
Enrollment	90
Start date	29 April 2016
Primary completion	29 July 2016
Estimated completion	30 August 2016
Sites	1 location across Spain

Drugs / interventions tested

• Celergen Administration

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Celergan SA

Who can join

18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of marine sperm extract, hydrolyzed collagen, CoQ10, lutein and selenium. This is an open-label, prospective, study to evaluate the efficacy and tolerability of Celergen in 90 patients with Fibromyalgia. The study duration was 90 days and patients were evaluated by the: FIQ-R Fibromyalgia Impact Questionnaire Revised, Questionnaire of Health SF-12, Scale Clinical Global Impression Improvement assessed by the patient (PGI), and the Brief Pain Inventory (BPI). Blood samples were obtained at weeks 0 and 12 order for serum levels of Substance P and Tumor Necrosis Factor to measured blindly. Statistical analysis will be performed by analysis of variance for paired data.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of an Extract of Salmon Milt on Symptoms and Serum TNF and Substance P in Patients With Fibromyalgia Syndrome.
   Tsilioni I, Pipis H, Freitag MSC, Izquierdo MDC, et al · · 2019 · cited 3× · PMID 31303280 · DOI 10.1016/j.clinthera.2019.05.019