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.
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)
