CTRI/2020/06/025658尚未招募4 期
A PROSPECTIVE, RANDOMIZED COMPARATIVE, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAYA KALPA VATI AND SEABUCK THORN OIL IN COMPARISION WITH ORAL METHOTREXATE AND TOPICAL STEROID IN CHRONIC PLAQUE PSORIASIS
National Institute of Medical Sciences and Research Centre1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2020年10月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Reduction in PASI score
研究概览
简要总结
This study is a randomised interventional trial to compare the safety and efficacy of kaya kalpa Vati 2 tab thrice daily and sea buck thorn oil twice application with oral methotrexate 15mg once weekly and topical mometasone cream twice application for 16 weeks in 122 patients with chronic plaque psoriasis that will be conducted in NIMS Jaipur in India. The primary outcome measures will be reduction in PASI and improvement in DLQI at 8 weeks. The secondary outcome will be reduction in PASI score and improvement in DLQI at 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with chronic plaque psoriasis.
- •2.Psoriasis of both sex and age group more than 18 years.
- •3.All newly diagnosed and old cases of psoriasis.
- •4.Patients with PASI(psoriasis area severity index) score above10-
- •5.Patients with involvement of >10% body surface area.
排除标准
- •Patient who do not give consent for the study.
- •Patient on any therapy of psoriasis for past 3 months.
- •3.Patient having any other chronic debilitating diseases or other chronic skin disorders.
结局指标
主要结局
Reduction in PASI score
时间窗: 8weeks
Improvement in DLQI
时间窗: 8weeks
次要结局
- Reduction in PASI score(Improvement in DLQI)
研究者
研究点 (1)
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