A Randomized Open Label Clinical Trial on the Efficacy of an Ayurvedic Treatment Package on Symptom Severity and Quality of Life in Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Psoriasis-specific quality of life
研究概览
简要总结
Psoriasis is a chronic, immune-mediated inflammatory skin disease that is associated with substantial impairment of physical and psychological quality of life. The conventional treatment protocols manages the condition but with remissions and relapses which create anxiety in patients. Many of the patients withdraw from active social life as the disease attains chronicity. Several studies are pointing towards a conjoint management strategy incorporating the traditional and alternate medical systems. In this regard, Ayurveda is commonly used by psoriatic patients in India. Considering this fact it is high time to conduct a study to scientifically evaluate the efficacy of Ayurvedic treatment protocol in managing psoriasis as well as its potential to improve the quality of life.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with psoriasis having age 18 years or more
- •Patients with moderate-to-severe plaque psoriasis with a PASI score of 12 or higher
- •Psoriasis diagnosed 6 months or more before study entry
- •Those who are poorly controlled based on physicians assessment with topical treatments, phototherapy, systemic therapy, or a combination of these therapies.
- •Participants who have given informed consent.
排除标准
- •Participants with other systemic illnesses
- •Lactating and pregnant mothers.
- •Alcohol dependence/Narcotic dependence /Steroid dependence
- •In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
研究组 & 干预措施
Internal ayurvedic treatment
All possible internal preparations will be administered for a period of 12 months.
All administered preparations with its dosage and duration will be documented All preparations will be subjected to lab test for clearing heavy metal and pesticide content before the administration
干预措施: Individualized internal ayurvedic treatment (Drug)
External ayurvedic treatment
Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
干预措施: External ayurvedic treatment (Other)
结局指标
主要结局
Psoriasis-specific quality of life
时间窗: 6 months
Psoriasis specific DLQI scores
次要结局
- Psoriasis Severity(12 months)
- Adverse events(12 months)
- Psoriasis-specific quality of life(12 months)
研究者
Holger Cramer
Professor
Universität Duisburg-Essen