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临床试验/CTRI/2022/05/042423
CTRI/2022/05/042423已完成3 期

A comparative study to evaluate the role of Virechana and Bhringrajadi Lepa on Shwitra with special reference to Vitiligo in children

National Institute of Ayurveda Jaipur Rajasthan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月16日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Primary Outcome Measures- VASI Score

研究概览

简要总结

Recently rapidly increasing incidences of Shwitra is a challenge for medical world. Vitiligo is the pigmentary disorder of certain hereditary and acquired and autoimmune causes and characterized by depigmented or hypopigmented patches that results from absence or depleted in melanocytes. Pathogenesis of vitiligo points towards autoimmune hypothesis1 and disease may start at any age with increased incidences in first and second decade of life. Based on some dermatological out patient records the incidences are roughly estimated to be between 3-4% in India. However, vitiligo affects the estimated 1-2%of world population which is quite significant2. Present study has been designed to study the role of Samshodhan Karma followed by BhringrajadiLepa, externally, over the discoloured patches in children with subsequent exposure to sunlight. BhringrajadiLepa has been quoted in the classics (Bhrihad Nighantu Ratnakar by Khemraj Shri Krishna Das, Chapter-Tvagadosha,

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
5.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient of either sex between age group of 05 -15 years 2.Children diagnosed as vitiligo as per contemporary medical science or Shwitra as per clinical features mentioned in Ayurvedic texts.

排除标准

  • 1.Children below 05 and above 15 years of age.
  • 2.Children with Albinism will be excluded.
  • 3.White anesthetic spots, which are characteristic of leprosy will be excluded.
  • 4.Old refractory cases not responding after extensive use of modern medicine will be also excluded.
  • 5.One year old vitiligo patch will be excluded.
  • 6.Patches in genital and lip area will be excluded.

结局指标

主要结局

Primary Outcome Measures- VASI Score

时间窗: baseline, 15th day

次要结局

  • Cosmetic concern of the patient regarding depigmentation of the skin(baseline, 15th day)

研究者

发起方
National Institute of Ayurveda Jaipur Rajasthan
申办方类型
Research institution and hospital

研究点 (1)

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