Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 主要终点
- Change in NFϰB expression
研究概览
简要总结
Psoriasis affects around 4% of world population. The disease could be disabling and disfiguring dermatologic condition. World Health Organization (WHO) has recently drawn the attention to the inadequate treatment options psoriasis patients suffer from among other problems. Furthermore, the available treatment options have many side effects. A lot of the effective treatment options are either expensive or not appropriate for hepatic patients who represent a large subset of Egyptian psoriatic patients. This highlights the need for inexpensive and safe alternative. The effectiveness of Turmeric in psoriasis treatment have been addressed in few reports. Having an immune modulatory effect especially as anti NFκB it is expected to be effective therapy with minimal side effect. Up to the investigator's knowledge this is the first study addressing the efficacy of combined turmeric and olive oil based topical therapy in psoriasis treatment
详细描述
Psoriasis is a prevalent skin disorder. It affects around 4% of world's population. It can be disfiguring and disabling in severe cases. There is dysregulated immune response in psoriatic patients to unknown injurious agents with upregulation of Th1/Th17 pathways which is mediated via Nuclear Factor kappa B (NFκB). NFκB is a key player in psoriasis development; its activation and nuclear translocation is present in every step of the way of psoriasis starting from keratinocyte release of cytokines -in response to stress- to the maturation and activation of dendritic cells, to the continuous loop of T cell activation.
Turmeric extract has anti-inflammatory, anti-oxidant, anti-microbial and anti-carcinogenic effects. It has inhibitory effects on NF-κB and various cytokines production.
In this clinical trial 5 groups of patients with mild to moderate psoriasis are recruited; group (A) Receiving the Turmeric extract based ointment only. Group (B) receiving Turmeric extract + olive oil based treatment. Group (C) will serve as negative control receiving only petrolatum base. Group (D) will receive NB UVB serving as positive control. Group (E) will receive established topical treatment serving as positive control.
Each patient will be assessed on weekly bases clinically for the disease severity using PASI score and via dermatoscope. Histopathological evaluation (H& E along with NFkB expression analysis) will be done at 4 points of time baseline, 4 weeks, 8 weeks, 12 weeks through the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patients do not know whether they are receiving the drugs with active ingredients or negative control. The pathologist will be masked regarding the groups and the point of time before or after therapy.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate psoriasis vulgaris of any age & gender.
- •Patient didn't receive any systemic or topical therapy for psoriasis the last 4 weeks.
排除标准
- •Patients previously received topical or systemic therapy for psoriasis in the past 4 weeks.
- •Patients with pustular or erythrodermic psoriasis.
- •Patients with other dermatological diseases.
- •Patients have hypersensitivity from the active ingredients of the therapy.
研究组 & 干预措施
Turmeric Extract group
10 psoriasis patients receiving turmeric based ointment levigated in glycerin twice daily and assessed for response and side effects weekly for 12 weeks
干预措施: Turmeric Extract (Drug)
Turmeric extract + olive oil group
10 psoriasis patients receiving turmeric extract levigated in olive oil instead of glycerin. The ointment will be applied twice daily for 12 weeks & will be assessed weekly
干预措施: Turmeric Extract in Olive oil (Drug)
Petrolatum group
10 Psoriasis patients will receive the base of the therapeutic ointment which is the petrolatum. Patients will apply it twice daily and will be assessed weekly clinically and dermoscopically for 12 weeks
干预措施: Petrolatum (Drug)
NBUVB group
10 Psoriasis patients will receive two sessions of NBUVB weekly for 12 weeks and will be assessed weekly clinically and with dermoscope.
干预措施: NB-UVB (Device)
Established ttt group
10 Psoriasis patients will receive topical betamethasone dipropionate or calcipotriol cream twice daily for 12 weeks and will be assessed on weekly basis clinically and by dermoscope
干预措施: calcipotriol/ Betamethasone (Drug)
结局指标
主要结局
Change in NFϰB expression
时间窗: Baseline and every 4 weeks till the end of 12 weeks.
The NFϰB expression will be identified by the percentage of positive nuclear stained epidermal cells in slide at base line and every 4 weeks till the end of study which is 12 week
Change in psoriasis severity
时间窗: Weekly basis for 12 weeks
Response to therapy will be assessed using dermatoscope with software mediated image analysis.
Change in Psoriasis Area & Severity Index (PASI)
时间窗: 12 weeks
Response to therapy is assessed via measurement of (PASI) every week for 12 w. The range of PASI score is from 0 (no disease) - 72 (sever disease). In PASI, the body is divided into four sections (head; arms; trunk; legs). Each of the sections is scored by itself, and then the four scores are combined into the final PASI. For each section, area of involved skin is given a grade from 0 to 6: 0= 0% of involved area, 1 = \< 10% involved, 2=10-29% involved, 3 =30-49% involved area, 4 = 50-69% involved, 5 =70-89% involved, 6 = 90-100%involved. Within each section, the severity is estimated in three clinical parameters: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of three severity parameters is calculated for each section of body, multiplied by the area score for that section and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs).
Change on pathology level
时间窗: Baseline and every 4 weeks for the period of the study (12 w)
Histopathologic evaluation of hematoxylin and eosin stained slides from psoriatic lesions before and after treatment or placebo. The slides will be given a score based on the presence or absence of each of the following: Hyperkeratosis (0.5), One mitosis/3 rete ridges (0·5), Acanthosis (1),Dermis lymphocytic infiltrate; Mild (0·5) Moderate (1) Marked (2·0) Parakeratosis (1),Papillary congestion (0.5),Lack of granular layer (1), Munro abscesses (2), Thinning above the papillae (0.5), Length of rete ridges (0.5), Clubbing of rete ridges (0·5). The sum score of each patient's slide will be recorded at baseline \& every 4 week
次要结局
未报告次要终点
研究者
Hagar Nofal
Assistant Lecturer, Principal Investigator
Zagazig University