Is 100% Pure Stabilized Whole Rice Bran (SWRB) Effective When Used as a Cleanser and an Emollient in Patients With Mild to Moderate Atopic Dermatitis?
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- SCORAD index change
研究概览
简要总结
This clinical trial serves to look at the effectiveness of SWRB for the treatment of mild to moderate Atopic Dermatitis in patients below the age of 18. Atopic Dermatitis (AD) is a common condition seen in dermatology, paediatric and primary care clinics in Malaysia. AD poses a significant biopsychosocial burden among sufferers and their families. Current management patterns of AD sufferers in South-east Asia mainly involve use of topical moisturizers and topical corticosteroids.
Rice bran and products derived from it have been studied regarding their anti-oxidant, nutritional, cholesterol lowering and health promoting properties. However, there are very few studies that have focused on the benefits of SWRB when used topically.
SWRB is cost-effective and easily available, while being an under-utilised product. The investigators wanted to study its effectiveness in controlling the signs and symptoms of Atopic Dermatitis when used as a cleanser and topical paste (emollient) as very little is known on this subject.
The investigators wish to study participants below 18 years of age with mild and moderate Atopic Dermatitis.
The participants will be followed up for four to six (4 - 6) weeks and the clinical features tabulated. This study does not involve any enteral or parenteral administration of SWRB.
Neither does it involve any invasive procedures.
详细描述
Objective of the study To study whether the natural product, SWRB, is effective to control the symptoms and signs of mild to moderate Atopic Dermatitis (AD)
Background, rationale & justification.
- Atopic Dermatitis is a common condition seen in dermatology, paediatric and primary care clinics in Malaysia. The overall prevalence of Atopic Dermatitis in the paediatric population in Malaysia was shown to be around 13.4% in 2018 (Goh et al., 2018)
- AD poses a significant biopsychosocial burden among sufferers and their families. (Carroll et al., 2005). Current management patterns of AD sufferers in South-east Asia mainly involve use of topical moisturizers and topical corticosteroids (Chan et al., 2006).
- There are many concerns among parents of sufferers of AD regarding the side effects of these therapies, causing them to seek alternative therapies (Lee and Bielory, 2010).
- Many emollients are available in the market which are either occlusives, hemectants or both. There are also bath emollients and directly applied ones. Very little has been studied regarding their effectiveness. Emollients available may also contain preservatives and fragrances that can prove to be irritants when applied topically (Rubel et al., 2013).
- Rice bran and products derived from it have been studied regarding their anti-oxidant, nutritional, cholesterol lowering and health promoting properties (Nagendra Prasad et al., 2011).
However, there are very few studies that have focused on the benefits of SWRB when used topically. 6. Justification: SWRB is cost-effective and easily available, while being an under-utilised product. The investigators wanted to study its effectiveness in controlling the signs and symptoms of Atopic Dermatitis when used as a cleanser and topical paste (emollient) as very little is known on this subject.
Methodology This is a clinical trial involving topical therapy with pure SWRB which is in powder form, on patients below 18 years of age, who suffer from mild to moderate atopic dermatitis. The SWRB is from locally grown rice and locally milled rice bran. This has been recently stabilised, for the first time in Malaysia, and made suitable for human use by Rice Bran Nutraceuticlas Sdn. Bhd (RBN). The SWRB is provided Free of Charge for this Study by RBN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients below 18 years of age with mild and moderate Atopic Dermatitis
排除标准
- •Those over 18 years of age
- •Patients with other forms of dermatitis
- •Severe disease
- •Those already on other forms of topical therapies, which are likely to interfere with outcomes
研究组 & 干预措施
Stabilised Whole Rice Bran (SWRB)
Patients with mild AD will be given SWRB in powder form, to be used as a cleanser after adding water to it according to set proportions given as instructions, one time per day.
Patients with moderate disease will be instructed to use SWRB as a cleanser as above. In addition, they will also use SWRB as an emollient after constituting it into a paste as in instructions, apply at night and leave it overnight.
干预措施: Stabilised Whole Rice Bran (Drug)
结局指标
主要结局
SCORAD index change
时间窗: 4 weeks
Used to assess the effectiveness of treatment, done after treatment. http://scorad.corti.li/
次要结局
未报告次要终点