The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS)
研究概览
简要总结
Study about the effect of ethanol extract physalis angulate in scleroderma patients with standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce inflammation, immunological response and fibrosis: A Randomized Clinical Placebo ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to July 2017
详细描述
Background.
Scleroderma is a systemic autoimmune disease that can not be cured, the progression of the disease still difficult to prevent and lead to increased morbidity and mortality. Disease-modifying anti-rheumatic drugs (DMARDs) as standard immunosuppressant drugs to reduce, eliminate, inhibit inflammation and fibrosis in scleroderma patient is still less effective.
Objectives.
To evaluate the effect of ethanol extract of Physalis angulate Linn to reduce skin fibrosis based on MRSS, ESR, BAFF, sCD40L, and P1NP in scleroderma patients with standard therapy
Methods.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind randomized placebo controlled trial
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the criteria of the type of limited scleroderma diagnosis / limited or diffuse type.
- •Patients who routine control in rheumatology outpatient clinics in Ciptomangunkusumo hospital Jakarta and Hasan Sadikin hospital Bandung RSHS who received standard therapy for scleroderma with a stable dose over the past 3 months.
- •The research subjects aged 15 to 60 years.
- •Subjects with modified Rodnan Skin score ≥
- •Disease duration ≥ 1 year
排除标准
- •Impaired liver function with cirrhosis
- •Chronic Renal dysfunction (chronic kidney disease stages 4-5). Or creatinine levels> 2 mg / dL in the last 1 month prior to randomization.
- •Other autoimmune disease/overlap syndrome.
- •Received a steroid/prednisone >10 mg/day in the last 1 month.
- •Patients who are pregnant or breastfeeding.
- •Patients with active tuberculosis and or are being treated with anti-tuberculosis medicines.
- •Severe heart disease. (Heart Disease with impaired function according to the New York Heart Association Class III or IV)
- •History of allergies to herbal Ciplukan / Physalis angulate Linn. or a history of hypersensitivity to certain drugs.
- •Hypotension (BP <90/60 mmHg)
- •Hypoglycemia (Glucose level <70 mg / dL)
- •Do not want to participate in the study
结局指标
主要结局
Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS)
时间窗: 3 months of intervention
Clinical improvement of skin fibrosis in scleroderma patients measured by modified Improvement in skin fibrosis is defined if there is a significant reduced of mRSS.
次要结局
- Level of P1NP serum(3 months of intervention)
- Level of sCD40L serum(3 months of intervention)
- Value of ESR(3 months of intervention)
- Level of BAFF serum(3 months of intervention)
研究者
Sumartini Dewi
MD, Master of Health
Indonesia University