Effectiveness of Individualized Homoeopathic medicine (IH) and Arsenic Sulphuratum Flavum (ASF) in LM Potency in Vitiligo-A Single blind, Randomized, Comparative, Parallel group study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change in Vitiligo European Task Force (VETF) scale
研究概览
简要总结
The present study has been designed to compare the response to individualized homoeopathic treatment in LM scale and ASF in LM scale in vitiligo, using standardized parameters for assessment.
The study will be conducted in compliance with this protocol, according to Declaration of Helsinki and Good Clinical Practice in India.
Null hypothesis (H0)
There is no significant difference between IH and ASF with respect to change in area, stage and
spread of depigmented patchesin patients of Vitiligo measured on identified parameters.
Alternative Hypothesis (Ha)
There is a significant difference between IH and ASF with respect to change in area, stage and
spread of depigmented patches in patients of Vitiligo measured on identified parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Vitiligo lesion (1 or more) on any part of the body.
- •At least one patch to be more than 3cm in length and 3cm in width.
- •Patients of 18 year or more age group and both sex.
- •Patient giving written consent for study and photographic evidence.
排除标准
- •• Patients on any other (allopathic/ ayurvedic/ naturopathic) treatment either topical or systemic for Vitiligo.
- •• Patient on laser or Phototherapy treatment for Vitiligo lesion.
- •• Patient on treatment with immune-modulating oral medications for other NCD or systemic illnesses.
- •• Patient suffering with other skin conditions (like dermatophytosis, scabies, ringworm, eczema etc.) • Patients with hypothyroidism, or vitamin B 12 deficiency(below 200 pg/mL).
- •• Pregnant women.
结局指标
主要结局
Change in Vitiligo European Task Force (VETF) scale
时间窗: At baseline and every month till 12 month
次要结局
- Change in(1) Vitiligo Quality of life (VitiQoL))
研究者
Dr Renu Bala
Central Research Institute (Homoeopathy) under Central Council for Research in Homoeopathy