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Efficacy and Tolerability of CELERGEN in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03911882
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Celergan SA

Brief 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.

Condition or disease Intervention/treatment
Fibromyalgia Dietary Supplement: Celergen Administration

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Open-label, Study to Evaluate the Efficacy and Tolerability of the Food Supplement CELERGEN in Patients With Fibromyalgia
Actual Study Start Date : April 29, 2016
Actual Primary Completion Date : July 29, 2016
Actual Study Completion Date : August 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Celergen Administration
The food supplement Celergen was administered to fibromyalgia patients following a protocol of a daily intake for the period of a total of 3 months (90 days)
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




Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire Revised [ Time Frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end) ]
    Scale measuring overall fibromyalgia symptoms (0-100) For each symptom-based item (Questions 14 - 20) the raw score ranges from 0 to 10. If the patient marks between 2 hash marks the item is given a score that includes 0.5. Do Job: (Question 14) Raw score is final score. Pain: (Question 15) Raw score is final score. Fatigue: (Question 16) Raw score is final score. Rested: (Question 17) Raw score is final score. Stiffness: (Question 18) Raw score is final score. Anxiety: (Question 19) Raw score is final score. Depression: (Question 20) Raw score is final score. In each instance, the final score is the sum of the scores for the Physical Impairment, Feel Good, Pain, Fatigue, Rested, Stiffness, Anxiety, and Depression scales (does not include 2 work items.)

  2. Brief Pain Inventory [ Time Frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end) ]

    Scale measuring pain frequency and intensity (0-10) Brief Pain Inventory (Short Form) 2. On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most.

    Yes No 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 4. Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours. 6. Please rate your pain by marking the box beside the number that tells how much pain you have right now.

    0 1 2 3 4 5 6 7


  3. Questionnaire of Health SF-12 [ Time Frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end) ]

    Scale measuring quality of life (0-100) Choose one option for each questionnaire item.

    1. In general, would you say your health is:

    1. - Excellent
    2. - Very good
    3. - Good
    4. - Fair
    5. - Poor

    2. For how long (if at all) has your health limited you in each of the following activities?

    Limited for more than 3 months Limited for 3 months or less Not limited at all

    1. The kinds or amounts of vigorous activities you can do, like lifting heavy objects, running or participating in strenuous sports

      1 2 3

    2. The kinds or amounts of moderate activities you can do, like moving a table, carrying groceries, or bowling

      1 2 3

    3. Walking uphill or climbing a few flights of stairs

      1 2 3

    4. Bending, lifting, or stooping

      1 2 3

    5. Walking one block

      1 2 3

    6. Eating, dressing, bathing, or using the toilet

      1. 2 3 3. How much bodily pain have you had during the past 4 weeks:
      1. - None
      2. - Very mild
      3. - Mild
      4. - Moderate

  4. Clinical Global Impression Improvement assessed by the patient (PGI) [ Time Frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end) ]

    Scale measuring overall improvement (0-7) Severity scale The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are:[1]

    Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients Improvement scale The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:[1]

    Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse



Secondary Outcome Measures :
  1. Serum TNF level [ Time Frame: Compare levels at T=1 week with levels at T=12 week ]
    ELISA measurement

  2. Serum Substance P level [ Time Frame: Compare levels at T=1 week 1 with levels at T=12 week ]
    ELISA measurement


Biospecimen Retention:   Samples With DNA
Serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult Caucasian 18-60 years
Criteria

Inclusion Criteria:

  • Adult patients with an established diagnosis of fibromyalgia according to the diagnostic criteria of the American College of Rheumatology of the year 2010.
  • Patients who signed the informed consent to participate in the study

Exclusion Criteria:

  • Patients suffering from any psychiatric disorder specified on Axis I DSM-IV- R other than major depression.
  • Patients with a history or currently part of substance abuse.
  • Patients who are pregnant or breastfeeding.
  • Patients taking other dietary supplements with or without antioxidant character, or who are being treated with ozone therapy systemically.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911882


Locations
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Spain
Clinica DFK
Madrid, Spain
Sponsors and Collaborators
Celergan SA
Investigators
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Study Director: Karin Freitag Clinica DFK, Madrid, Spain

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celergan SA
ClinicalTrials.gov Identifier: NCT03911882     History of Changes
Other Study ID Numbers: CELERGEN6007
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Celergan SA:
Fibromyalgia
Cytokines
TNF
Substance P
Spermine
Pain
Fatigue

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases