NCT00235625已完成2 期
A Phase II Open Label Study of the Safety and Efficacy of Curcuminoids C3 Complex® in Patients With Chronic Psoriasis Vulgaris.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Physicians Global Assessment (PGA) of Change
研究概览
简要总结
Turmeric (Curcuma Longa) is member of the ginger family and is best known for its culinary use as the major of component of curry powder. The volatile of oils (called curcuminoids) of the turmeric root, however, have anti-inflammatory actions which make them promising candidates for the treatment of psoriasis. For example, curcumin has been shown to improve psoriasis in experiments using in vitro models. Turmeric has been shown to have minimal side effects in doses up to 12 grams per day. The purpose of this study is to determine the safety and to estimate the efficacy of oral Curcuminoid C3 Complex® in patients with chronic psoriasis vulgaris.
详细描述
This study is no longer recruiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have chronic plaque type psoriasis that, in the investigator's opinion is clinically stable and does not require urgent treatment with standard, FDA approved psoriasis therapies.
- •Psoriasis must cover at least 6% of subject's body surface area and lesions must have moderate plaque thickness
- •Subjects must be willing to and have the capacity for giving written informed consent
- •Ages 18 to 75
- •Subjects must be available for the total duration of the study (16 weeks)
- •Female subjects that are sexually active with male partners must be postmenopausal, surgically incapable of childbearing, or be using a medically acceptable method of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or partner include oral contraceptives or patch, diaphragms with spermicide, IUD, condom with spermicide, or progestin implant or injection. Females taking oral contraceptives must have taken them consistently for at least two months prior to receiving study medication. All female subjects must consent to a urine pregnancy test at screening and at start of study, which must be negative at both time points. Male subjects who are sexually active with female partners and are capable of fertilization must ensure that their female partners will either be postmenopausal, surgically incapable of childbearing, or will use a medically acceptable method of contraception throughout the entire study period
排除标准
- •Females subjects who are pregnant or nursing a child •Subjects who are sensitive to or allergic to turmeric or curry powder •History of alcohol or drug abuse within 12 months of screening visit •Subjects with rapidly improving or deteriorating psoriasis or the following more variable types of psoriasis: guttate, erythrodermic, or pustular psoriasis •Use of systemic treatments for psoriasis (including methotrexate, cyclosporine, alefacept, adalimumab, efalizumab, infliximab, etanercept, etretinate, systemic steroids and PUVA) within 3 months prior to day 0 or at any time during the study. •Use of topical treatments and UVB therapy for psoriasis (not including non-medicated emollients or shampoos) within 14 days prior to day 0 or at any time during the study period. •Subjects, who have received an experimental drug, used any experimental medical devise within 30 days prior to screening •Clinically significant laboratory abnormalities •Subjects with significant medical comorbidities •Subjects for whom the dose of the following medications has changed within 1 month of day 0: clonidine, digoxin, beta-blockers, lithium, or anti-malarials •Subjects unable to swallow pills •Subject who are unable to adhere to the protocol for any reason
结局指标
主要结局
Physicians Global Assessment (PGA) of Change
时间窗: November 2007
次要结局
- PASI (Psoriasis Area Severity Index)(November 2007)
- quality of life (Skindex-29)(November 2007)
- pharmacodynamic activity (via skin biopsies and serum cytokines)(December 2007)
研究者
研究点 (2)
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