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临床试验/CTRI/2018/04/013446
CTRI/2018/04/013446已完成3 期

Effectiveness of individualized homoeopathic medicines and Psoralea corylifolia mother tincture external application in vitiligo: an open randomized pragmatic trial

National Institute of Homoeopathy Ministry of AYUSH Govt of India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月26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
60
试验地点
1
主要终点
Vitiligo Area Scoring Index (VASI)

研究概览

简要总结

Vitiligo is a common chronic skin depigmentationdisorder. It is due to stoppage of melanin formation by the melanocytes and presentsas asymptomatic depigmented macules anywhere on the body including mucousmembranes of lips and genitalia. In vitiligo, there is a marked reduction or evenabsence of melanocytes and melanin in the epidermis. It affects around 0.5%-1% of the world population. As high as 8.8% prevalence have been reported inIndia, where considerable stigma is attached to the disease. Vitiligo patches can appear anywhere on theskin, but commonly affected sites include the area around the orifices, thegenitals or any sun-exposed areas such as the face and hands. The hair andrarely, the eyes may also be affected. Fifty percent of cases appear before the age of20, with the disfigurement resulting in psychiatric morbidity in 16-35% ofthose affected. Depression, sleep disturbances, suicidal thoughts, suicidal attempts,difficulties in relationships, and avoidance of social situations have beenreported in individuals afflicted by vitiligo before adulthood. In India, in particular, it ranges from 6.25-18%.Some studies reveal it as high as 40%. In 19th century, practitioners acknowledged limitations fortreatment of this condition and suggested Sulphide of Arsenicum to lessen thepatch. The homoeopathic literature suggest a number of medicines for the conditions. In a recent review, 11 research papers related to homoeopathy on vitiligowere identified. The investigators also identified a recentlypublished case series revealing promising role of homoeopathy in treatment ofvitiligo. Under such circumstances, the authors considerit very important to undertake a pragmatic trial with adequate methodologicalrigor. In this prospective, open, randomized, three parallelarms, pragmatic trial, 60 patients suffering from vitiligo will be randomized to either individualized homeopathic medicines (IH; n=20), or Psoralea corylifolia mother tincture external application (PC; n=20), or both (IH + PC; n=20). Outcomes will be measured in terms of VASI, VitiQoL, and DLQI, measured at baseline, after 3 months, and after 6 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18-65 years
  • Both sexes
  • Literate; able to read English or Bengali
  • Suffering from vitiligo for at least last 3 months.

排除标准

  • Patients who are too sick for consultation
  • Patients not giving consent to take part
  • Diagnosed cases of unstable psychiatric illness or other systemic disease or infection affecting quality of life or any vital organ failure
  • Pregnancy and lactation
  • Self-reported immune-compromised state
  • Substance abuse and/or dependence
  • Undergoing homeopathic treatment for any chronic disease within last 6 months.

结局指标

主要结局

Vitiligo Area Scoring Index (VASI)

时间窗: Baseline, after 3 months and after 6 months

次要结局

  • Vitiligo Quality of Life Questionnaire (VitiQoL)(Baseline, after 3 months and after 6 months)
  • Dermatological Life Quality Index (DLQI) questionnaire(Baseline, after 3 months and after 6 months)

研究者

发起方
National Institute of Homoeopathy Ministry of AYUSH Govt of India
申办方类型
Private medical college

研究点 (1)

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