An Analytical Study to Develop and Validate a Tool for Assessing the Severity of Shvitra and Evaluate Its Concordance Through Intervention.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in severity of lesion or completion in study period whichever is earlier.
研究概览
简要总结
This study aims to develop and validate the Shvitra Severity Scale to assess the severity of vitiligo in patients. The primary objective is to create a validated tool for classifying patients based on their condition’s severity, aiding treatment decisions. The secondary objective evaluates the efficacy of two Ayurvedic treatments Shashilekha Vati 250 mg twice a day internally and Bakuchi Taila externally for 90 days. Treatment outcomes will be assessed after 90 days using the developed Shvitra Severity Scale, Wood’s lamp Mexameter interferon-gamma levels CXCL10 gene expression and the VIS-22 quality of life questionnaire. This study fills a gap by introducing a validated severity scale improving patient classification treatment evaluation and supporting evidence based Ayurvedic practices for vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient fulfilling 2024 ICD-10-CM Diagnosis Code L80 criteria.
- •Patient presenting with Saadya Lakshana of Shvitra (~Vitiligo) Generalized and segmental stable vitiligo.
- •Patient who will give informed consent.
排除标准
- •Active vitiligo defined by presence of confetti lesions trichrome lesion and Koebner phenomenon.
- •Pregnant women and breastfeeding or those who have recently delivered a baby within the past 6 months.
- •Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks.
- •Topical steroids within the prior 2 weeks.
- •Currently undergoing UVB light therapy or history of light therapy within the past 8 weeks.
- •Enrolled in a clinical study of any other investigational drug or device.
- •Prescription medication or cosmetics containing: retinoids glycolic acid salicylic acid or any other remedies that might affect the healing process.
- •Non-medicated moisturizers are allowed.
- •Self-reported history of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance as judged by the investigation.
- •Subjects with active vitiligo treatment with other drug system for at least 3 months.
- •Lesions over the palms genital and burnt areas.
- •Subject having another systemic disease and other skin diseases.
- •Subjects with known allergies impaired cardiac hepatic and renal function.
- •History of malignancy.
- •Subjects suffering with Autoimmune disorders.
- •Any other condition or laboratory value that would in the professional opinion of the investigators potentially affect the subject response or the integrity of the data or would pose an unacceptable risk to the subject.
结局指标
主要结局
Changes in severity of lesion or completion in study period whichever is earlier.
时间窗: 0 day 1 month 2 month 3 month
次要结局
- This study evaluates changes in the Shvitra Severity Scale vitiligo extent using Wood’s lamp melanin content using Mexameter interferon-gamma levels using ELISA and CXCL10 gene expression using RT-PCR in participants treated with Shashilekha Vati internally and Bakuchi Taila externally over 90 days. Clinical validation of the tool will be achieved by correlating these parameters.(0 day 1 month 2 month 3 month)
研究者
Dr Anagha M S
All India Institute of Ayurveda