A Prospective, Open-label, Study to Evaluate the Efficacy and Tolerability of the Food Supplement CELERGEN in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical Global Impression Improvement assessed by the patient (PGI)
研究概览
简要总结
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.
详细描述
Fibromyalgia Syndrome (FMS) is a disease characterized by chronic widespread pain, along with muscle stiffness, sleep disorders, chronic fatigue, anxiety, depression, or neurocognitive deficiencies and autoimmune dysfunction. FMS prevalence is about 2% of the general population. Recently, a European study found a prevalence of 4.7% in all five countries surveyed, including Spain. The etiology of FMS is still unknown, but recent evidence supports the involvement of neuro-inflammation.
Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of a proprietory mixture of herring and mackerel milt semen and sperm-filled reproductive gland of male fish provided by Celergen Ltd, Luxemburg), 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 following:
INSTRUMENTS OF ASSESSMENT:
- Fibromyalgia Impact Questionnaire Revised (FIQR): The most commonly used scale to assess the severity and impact of fibromialgia.
- Brief Pain Inventory (BPI): Evaluates both pain intensity and interference with daily activities. The validated Spanish version will be used.
- Questionnaire of Health SF-12: This questionnaire, shortened version of the SF-36 version, has shown strong correlation with the latter both in relation to the physical and mental summary, presenting the advantage of its reduced complexity.
- Scale Clinical Global Impression Improvement assessed by the patient (PGI): A Likert scale of 7 points ranging from 1 (much better) to 7 (very much worse). It is used in most studies and clinical trials to assess the patients perception of the evolution of the disease in relation to the prescribed treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with an established diagnosis of fibromyalgia according to the diagnostic criteria of the American College of Rheumatology of the year
- •Patients who signed the informed consent to participate in the study
排除标准
- •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.
结局指标
主要结局
Clinical Global Impression Improvement assessed by the patient (PGI)
时间窗: 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
Brief Pain Inventory
时间窗: 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
Fibromyalgia Impact Questionnaire Revised
时间窗: 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.)
Questionnaire of Health SF-12
时间窗: 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
次要结局
- Serum Substance P level(Compare levels at T=1 week 1 with levels at T=12 week)
- Serum TNF level(Compare levels at T=1 week with levels at T=12 week)