Efficacy of Individualized Homoeopathic Medicines in Treatment of Vitiligo: Double-Blind, Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vitiligo area scoring index (VASI) evaluateing disease extent and severity
研究概览
简要总结
Vitiligo is an acquired de-pigmentation disorder characterized by loss of melanocytes from epidermis. Worldwide prevalence of Vitiligo ranges is 0.4 and 2% and in India the relative prevalence varied between 0.46 and 8.8%. Studies reveals apositive role of homoeopathy in Vitiligo where varying degrees of repigmentation was reported. In this prospective, doubleblind, randomised, placebo controlled, parallel arm trial at National Instituteof Homoeopathy, 60 patients suffering from vitiligo will be randomised in 1:1ratio into either individualised homeopathic medicines in 50 millesimal scaleor identical placebo. VASI will be used as the primary outcome measure and VitiQoLquestionnaire and DLQI as secondary outcome measures, measured at baseline, 3rdmonth and 6th month. At the end of 6 months, comparative analysiswill be carried out to detect group differences, if any. Results will bepublished in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Suffering from Vitiligo for at least last 3 months
- •Patients of both sexes
- •Age between 18-65 years
- •Literate; able to read English and/or Bengali
- •Patients who have not taken any treatment since last 2 weeks for Vitiligo.
排除标准
- •Patients who are too sick for consultation
- •Unwilling to take part and not giving consent to join the study
- •Unable to read patient information sheet
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure
- •Pregnancy and lactation
- •Substance abuse and/or dependence
- •Self-reported immune-compromised state
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
Vitiligo area scoring index (VASI) evaluateing disease extent and severity
时间窗: At baseline, 3rd month and 6th month
次要结局
- Vitiligo Specific Health Related Quality of Life Instrument (VitiQOL)(At baseline, 3rd month and 6th month)
- Dermatological Life Quality Index (DLQI) questionnaire(At baseline, 3rd month and 6th month)