Fibromyalgia Clinical Trial
Official title:
A Prospective, Open-label, Study to Evaluate the Efficacy and Tolerability of the Food Supplement CELERGEN in Patients With Fibromyalgia
NCT number | NCT03911882 |
Other study ID # | CELERGEN6007 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 29, 2016 |
Est. completion date | August 30, 2016 |
Verified date | March 2019 |
Source | Celergan SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | August 30, 2016 |
Est. primary completion date | July 29, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Clinica DFK | Madrid |
Lead Sponsor | Collaborator |
---|---|
Celergan SA |
Spain,
Catanzaro R, Celep G, Zerbinati N, Papacharalambous M, Nagpal R, Marotta F, Rastmanesh R, Milazzo M, Lorenzetti A, Bertuccelli G, Sollano J. In vitro protective effect of Celergen, a bioactive marine compound, on interleukin-6-related invasiveness of panc — View Citation
Catanzaro R, Zerbinati N, Solimene U, Celep G, Marotta F, Kushugulova A, Milazzo M, Tomella C, Bertuccelli G, Zhumadilov Z. Effect of Celergen, a marine derivative, on in vitro hepatocarcinogenesis. Drug Discov Ther. 2013 Oct;7(5):196-200. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia Impact Questionnaire Revised | 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.) | Compare values at T=week 1 (before treatment) with those at T=week 12 (end) | |
Primary | Brief Pain Inventory | 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 |
Compare values at T=week 1 (before treatment) with those at T=week 12 (end) | |
Primary | Questionnaire of Health SF-12 | Scale measuring quality of life (0-100) Choose one option for each questionnaire item. 1. In general, would you say your health is: - Excellent - Very good - Good - Fair - 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 The kinds or amounts of vigorous activities you can do, like lifting heavy objects, running or participating in strenuous sports 1 2 3 The kinds or amounts of moderate activities you can do, like moving a table, carrying groceries, or bowling 1 2 3 Walking uphill or climbing a few flights of stairs 1 2 3 Bending, lifting, or stooping 1 2 3 Walking one block 1 2 3 Eating, dressing, bathing, or using the toilet 2 3 3. How much bodily pain have you had during the past 4 weeks: - None - Very mild - Mild - Moderate |
Compare values at T=week 1 (before treatment) with those at T=week 12 (end) | |
Primary | Clinical Global Impression Improvement assessed by the patient (PGI) | 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 |
Compare values at T=week 1 (before treatment) with those at T=week 12 (end) | |
Secondary | Serum TNF level | ELISA measurement | Compare levels at T=1 week with levels at T=12 week | |
Secondary | Serum Substance P level | ELISA measurement | Compare levels at T=1 week 1 with levels at T=12 week |
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