CTRI/2024/10/075001尚未招募2 期
A Clinical Study to evaluate the safety and efficacy of Unani Formulations in Childhood Psoriasis
Department of Amraze Jild Wa Zohrawiya1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in PASI SCORE, PGA SCORE, BSA involved
研究概览
简要总结
To provide the safe and cost effective treatment of childhood psoriasis.
Null hypothesis: There is no significant effect of the trial formulations on the patients before and after the study
Alternate hypothesis: There is significant effect of the trial formulations on the patients before and after the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •PASI (Psoriasis Area and Severity Index) score more than 10
- •PGA (Physicians Global Assessment) score: 3–
- •BSA is more than 10%.
- •A clinically stable patient.
- •Patients up to 15 years of age.
- •Patients of either sex.
- •Patients are not on any concomitant therapy.
- •Patients who have left the treatment at least 2 months ago.
- •The patient or guardian agreed and signed the written consent proforma.
排除标准
- •Doubtful cases of childhood psoriasis.
- •Childhood psoriasis with secondary infection.
- •Immunocompromised patients.
- •Patients above the age of 15 years.
结局指标
主要结局
Improvement in PASI SCORE, PGA SCORE, BSA involved
时间窗: Monthly assessment for 6 months +2 months follow up.
次要结局
- Improvement in itching erythema induration(Monthly assessment for 6 months plus two months follow up)
研究者
Hafsa Tariq
Ajmal Khan Tibbiya College
研究点 (1)
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