Efficacy and Safety of Topical Babchi Oil as an Adjuvant Therapy in Vitiligo: A Randomized Placebo-Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Vitiligo is a chronic depigmenting disorder characterized by loss of melanocytes resulting in depigmented patches on the skin. Although several treatment modalities are available including topical corticosteroids and phototherapy, consistent and sustained repigmentation remains difficult to achieve in many patients. Babchi oil derived from the seeds of Psoralea corylifolia has been traditionally used for pigmentary disorders and contains bioactive compounds that may stimulate melanocyte activity and promote repigmentation.
The present study aims to evaluate the efficacy and safety of topical Babchi oil as an adjuvant therapy in patients with vitiligo. In this randomized placebo controlled clinical study, forty patients with clinically diagnosed vitiligo will be enrolled and randomly allocated into two groups. The intervention group will receive topical Babchi oil applied twice daily for twelve weeks while the control group will receive placebo oil with identical appearance and application schedule.
Clinical outcomes will be assessed using validated scoring systems including Vitiligo Extent Tensity Index and physician global assessment along with patient satisfaction scores. Safety will be evaluated by monitoring adverse events during the study period.
The hypothesis of the study is that topical Babchi oil used as an adjuvant therapy can significantly enhance repigmentation in vitiligo lesions compared to placebo while maintaining a favorable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
入选标准
- •Age and Gender: Male or female patients aged 18 to 60 years,Clinically confirmed cases of stable, localized Non-Segmental Vitiligo (NSV).
排除标准
- •comprised a known history of hypersensitivity to Psoralea corylifolia preparations, pregnancy or lactation, use of systemic immunosuppressive therapy within the preceding three months, and the presence of other autoimmune or inflammatory skin disorders.
研究者
Sai Shiva Ram
Saveetha medical college and hospital,saveetha institute of medical and technical sciences
