Evaluate the Effect of Elimune Capsules
关键词
抽象
描述
This is an open-label study consisting of a 1 day Screening Period and a 28 day Treatment Period. During the Screening Period subjects will sign informed consent and eligibility will be determined by reviewing inclusion/exclusion criteria including history of plaque psoriasis. Demographics, medical history, medication history, height and weight will be recorded. A blood sample for pre-dose biomarker analysis will be collected. Subjects will take two Elimune capsules twice daily from Day 1 to Day 28. On Day 7 and Day 28 subjects will return to the site and provide a blood sample for biomarker analysis. Adverse events and concomitant medications will be recorded throughout the study. A Physician's Evaluation of Plaque Severity and Physician's Evaluation of Arthritis Severity will be performed on Day 1, Day 7, and Day 28.
日期
| 最后验证: | 01/31/2015 |
| 首次提交: | 09/24/2014 |
| 提交的预估入学人数: | 09/25/2014 |
| 首次发布: | 09/28/2014 |
| 上次提交的更新: | 12/06/2015 |
| 最近更新发布: | 12/07/2015 |
| 实际学习开始日期: | 08/31/2014 |
| 预计主要完成日期: | 01/31/2015 |
| 预计完成日期: | 01/31/2015 |
状况或疾病
干预/治疗
Dietary Supplement: Elimune capsules
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Elimune capsules Elimune capsules 2 capsules BID (four total capsules per day) | Dietary Supplement: Elimune capsules 2 capsules BID for 28 days |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures. 2. Males and females at least 18 years of age. 3. Except for plaque psoriasis with or without arthritis, subject is in generally good health. 4. Subject exhibits acutely active at least moderate to severe plaque-type psoriasis (> 5% BSA) with or without arthritis. 5. Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at screening for all female subjects who are not surgically sterile. 6. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year). 7. Subject is willing and able to cooperate to the extent required by the protocol. Exclusion Criteria: 1. Subject has known allergy or hypersensitivity to Vitamin D3, Folic Acid, Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin, Glycyrrhizin, and Hesperetin. 2. Subject has history of alcohol and/or illicit drug abuse. 3. Female subjects who are pregnant or breastfeeding. 4. History of use of any immunosuppressant products (e.g. Enbrel, Remicade, Humira) within 12 months of Day 1. 5. Use of oral corticosteroids, methotrexate, cyclosporine, ultraviolet light, or Soriatane for 90 Days prior to Day 1 and throughout the trial. 6. Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies that have not been stable for 30 days prior to Day 1 or will not be stable throughout the study. 7. Use of an investigational drug within 90 days prior to Day 1. |
结果
主要结果指标
1. Individual subject serum levels of biomarkers [28 Days]
次要成果指标
1. Physician's Evaluation of Plaque Severity [28 Days]
2. Physician's Evaluation of Arthritis Severity [28 Days]
