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临床试验/CTRI/2018/04/013058
CTRI/2018/04/013058已完成1/2 期

A Clinical study on the role of Pracchan karma, Jalaukawacharan and Kakodumbaradi lepa in the management of Shwitra(Vitiligo)

Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年6月12日最近更新:

试验速览

阶段
1/2 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Day 0, 30, 60 and 90.

研究概览

简要总结

A randomized parallel trial was done with the title "A clinical study on the role of Pracchan karma, Jalaukawacharan and Kakodumbaradi lepa in the management of Shwitra(Vitiligo)". Total 100 patients were registered in the trial. Out of which 83 patients were the final participants. Patients between 16-60 years of age having Shwitra(Vitiligo)  but not on lip, scalp, neck or whole body were registerd. 25 patients were advised Pracchan therapy, 25 patients were advised  Jalaukawacharan(Leech therapy),  25 patients were advised  the topical application of Kakodumbaradi lepa. 25 patients were advised  the control drug,i.e., Tacrolimus ointment 0.1%. In patients in whom Pracchan therapy was advised, only 22 continued till completion of  the trial. In patients in whom Jalaukawacharan(Leech therapy) was advised, 20 patients continued till completion of the trial. 22 patients given Kakodumbaradi lepa continued the treatment till completion of the trial. 19 patients given Tacrolimus ointment 0.1% continued till completion of the trial. The result of the trial was very impressive with the therapies and the kakodumbaradi lepa being very effective in Shwitra(Vitiligo) patients. The Pracchan therapy and Jalaukawacharan are the therapies indicated in ancient Ayurvedic texts for letting impure blood from the site of disease manifestation. These therapies help in removal of free radicals and other toxins accumulated in the site of disease manifestation. These therapies also improve blood circulation in the site of disease manifestation leading to increased supply of nutrients and oxygen via fresh blood flow which stimulates melanocytes thus leading to improvisation of color formation process which is hampered in Shwitra(Vitiligo). The Kakodumbaradi lepa consisted of equal proportions of dried powder of Bakuchi(Psoralea corylifolia) seeds, Kakodumbar(Ficus hispida) bark and Chitrak(Plumbago zeylanica) triturated in Cow’s urine till it becomes a fine paste which is then applied on the vitiliginous patches followed by sun-exposure for 10-15 minutes. All the three ingredients and UV rays of sunlight leads to stimulation of melanogenesis. The control drug Tacrolimus ointment 0.1% is a topical calcineurin inhibitor which acts by decreasing immune response at the site of disease manifestation. It works on the basis of autoimmune pathogenesis of Vitiligo.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Dignosed cases of Vitiligo.
  • Patients willing to participate in the trial and informed consent taken.

排除标准

  • Patients having lesions on lip, scalp or neck.
  • Patients with complete dipigmentation all over body.
  • Presence of any systemic disease.
  • Presence of any other skin disease.

结局指标

主要结局

Day 0, 30, 60 and 90.

时间窗: Day 0, 30, 60 and 90.

次要结局

  • Assessment was done on the basis of especially prepared proforma for assessing the safety of the procedures and the drugs(90 days)

研究者

发起方
Institute of Medical Sciences
申办方类型
Research institution and hospital

研究点 (1)

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