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临床试验/CTRI/2020/01/022884
CTRI/2020/01/022884尚未招募不适用

Clinical and patient-reported outcomes in patients receiving Siddha standard of care and allopathic standard of care for psoriasis: A prospective cohort study

Melaka Manipal Medical College1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2020年1月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
192
试验地点
1
主要终点
Number of patients reaching PASI 75 (75% improvement in the PASI score)

研究概览

简要总结

This is a prospective cohort study comparing clinical and patient-reported outcomes in two groups, Siddha standard of care and allopathic standard of care in 192 patients ( 96 patients in each group) with psoriasis. This study has been approved by the Kasturba Medical College and Kasturba Hospital Institutional ethics Committee and patients will be recruited only after taking the informed consent. This will be done in the Department of Dermatology, Venereology and Leprosy, Kasturba Hospital, MAHE, Manipal and Division of Siddha, Center for Integrative Medicine and Research (CIMR), MAHE, Manipal. Patients in both the groups will be observed till 4 months of treatment or till the attainment of PASI 75 and from the fifth month up to 1-year, every month patients will be telephonically followed up. The primary outcome measure will be the number of patients reaching  PASI 75. Secondary outcome measures will be the number of relapses in each patient, the number of patients with different grades of remission, time taken to achieve a different grade of remission, duration of remission, assessment of adverse drug reactions, improvement in the patient-reported outcome scores, cost-effectiveness ratio, change in the cytokine levels at the attainment of PASI 75 compared to the baseline level.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with PASI score >10 2.Patient with Psoriasis Vulgaris (plaque psoriasis) and palmoplantar type of psoriasis 3.Patients with no systemic therapy for the past four weeks or topical therapy for the past two weeks.

排除标准

  • 1.Pregnant and lactating women 2.Coexisting eczema or lichen planus 3.Patients on any systemic drugs known to exacerbate psoriasis 4.Patients who are on any other treatment for psoriasis.

结局指标

主要结局

Number of patients reaching PASI 75 (75% improvement in the PASI score)

时间窗: 0,1,2,3,4 months

次要结局

  • Number of relapses in each patient(Number of patients with different grades of remission)

研究者

发起方
Melaka Manipal Medical College
申办方类型
Research institution

研究点 (1)

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