An Open Clinical Trial to evaluate the effectiveness of Panchathiktha Ghritham as Internal and Kodiveli Thailam as External in the management of Kalanjaga Padai (Psoriasis) in children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
-  Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1.
研究概览
简要总结
INTRODUCTION: Psoriasis is defined as the characterization of proliferation of erythematous scaly eruptions, single or multiple disposed primarily on the extensor surfaces of the body. The scales are lamellated and silvery white. Children accounted for 12.5% of total psoriasis over a period of 13 years. Age of onset ranged from 4 days to 14 years, male and female incidence was equal and plaque type of psoriasis was the most common type in children. In Siddha System, all the skin disorders are brought under the clinical entity “Kuttamâ€. The siddha literature,â€Aathma Rachamirtham Ennum Vaithiya Saarasangiram†mentions the characteristics of kuttam as, White scaly patches that appears in foot, hand, lips, vertex, finger and wrists. In the Pediatric OPD of National Institute of Siddha nearly 8500 visits had recorded with symptoms ofPsoriasis (Kalanjagapadai) from 2012 to 2021. In this proposed research work, the polyherbal formulation of Panchathiktha ghritham (internal) and Kodiveli thylam (external) has potent Anti-inflammatory, Immunomodulatory, Wound healing and Antipsoriatic activities to treat the Kalanjagapadai (psoriasis) from the authenticated Sasthric Siddha literature. MATERIALS AND METHODS: A total of 30 patients within age limit of 5-12 years willing to participate in the study by signing consent and assent form will be enrolled in the study. Both male and female children are included. RESULTS AND DISCUSSION: Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1.
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
- 5.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Inclusion will be done based on PASI score in between 3-6 2 Willing to cooperate for taking photographs whenever required with consent.
- •3 Parent / legal guardian willing to sign in the informed consent.
排除标准
- •1 Psoriatic arthritis 2 Psoriasis with evidence of any other skin diseases 3 Psoriatic lesions with secondary infection 4 Atopic dermatitis 5 Tinea infection 6 Lichen simplex chronicus.
结局指标
主要结局
 Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1.
时间窗:  Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1.
次要结局
- 1 Improvement in the quality of life in children assessed by CDLQI(2 Reduction in Proportion of patient from depression assessed by Beck’s Depression Inventory)
研究者
Dr Karthika Prakasan
National Institute of Siddha
