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临床试验/CTRI/2023/04/051426
CTRI/2023/04/051426尚未招募2/3 期

Evaluation of add on-effect of Virechana in the management of Shvitra (vitiligo in children) along with Manjishtadi Kashaya, Siva Gutika and Gandhakadi lepa -An open label randomized comparative clinical study.

All India Institute of Ayurveda New Delhi1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Reduction in subjective symptoms, Vitiligo Extensive Tensity Index (VETI) score and increase in repigmentation

研究概览

简要总结

INTRODUCTION:

 Vitiligo is a common dermatological disorder of chronic depigmentation which is phenotypically characterized by white macules on the skin caused as a result of the systematic destruction of functional melanocytes. It is reported to have a global prevalence of 1% and an Indian incidence of 0.2 to 8.8%. Its common age of onset is 10 to 30 years. It affects both the genders almost equally, but females show earlier ages of onset, hence their predominance being marked in the childhood vitiligo.The exact etiology of vitiligo is poorly understood and is often considered as a multifactorial disease with a complex pathogenesis encompassing several postulations implicating autoimmune, cytotoxic, biochemical, oxidant–antioxidant, viral, and neural mechanisms for destruction of the melanocyte function in genetically predisposed. It is classified into two classes segmental and non-segmental. There is a probable symmetry in the location of patches in non-segmental type of Vitiligo. This class includes generalized, Universal, Focal, Acrofacial and Mucosal Vitiligo. Latter is static and mostly affects the area of skin attached with dorsal root of spinal cord unilaterally.

 OBJECTIVES: PRIMARY:Reduction in subjective symptoms, Vitiligo Extensive Tensity Index (VETI) score and increase in repigmentation among pediatric patients of 10-16 years age group of Shvitra(vitiligo) on giving virechana along with Manjishtadi Kashaya, Siva Gutika and Gandhakadi Lepa and only shamana chikitsa for the duration of 60 days.

         SECONDARY: Improvement in Children’s Dermatological Life Quality Index (CDLQI) among pediatric patients of 10-16 years age group of Shvitra (vitiligo) on giving virechana along with Manjishtadi Kashaya, Siva Gutika and Gandhakadi Lepa and only shamana chikitsa for the duration of 60 days.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
10.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Children of age group 10-16 years of either gender Patients with Sadhya Lakshana of Shvitra Patients having Shvitra patches with normal tactile sensation.
  • Patients who are willing to participate in study.

排除标准

  • Patients on any other oral/tropical medication.
  • Vitiligo associated with malignant melanoma, albinism, and psoriasis.
  • Patient suffering from other systemic diseases & autoimmune disorders.

结局指标

主要结局

Reduction in subjective symptoms, Vitiligo Extensive Tensity Index (VETI) score and increase in repigmentation

时间窗: 1st day | 61st day | 91st day

次要结局

  • Improvement in Children’s Dermatological Life Quality Index (CDLQI)(1st day)

研究者

发起方
All India Institute of Ayurveda New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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