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Efficacy and Tolerability of CELERGEN in Fibromyalgia

NCT03911882 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2019-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia

Interventions

DIETARY_SUPPLEMENT

Celergen Administration

The food supplement Celergen was administered on a daily basis for a total of 3 months (90 days) to participating fibromyalgia patients

Sponsors & Collaborators

  • Celergan SA

    lead INDUSTRY

Principal Investigators

  • Karin Freitag · Clinica DFK, Madrid, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-29
Primary Completion
2016-07-29
Completion
2016-08-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911882 on ClinicalTrials.gov