Single Arm Open Label Clincal Trial of Nimbadi Ghrita Lepam and Nimbadi Capsule in Vipadika (Palmoplantar Psoriasis)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
Palmoplantar psoriasis is a chronic painful and disabling immune mediated autoimmune skin disorder affecting approximately 2 to 3 percent of the global population with palmoplantar involvement seen in nearly 10 to 30 percent of psoriasis cases often associated with fissuring pain and marked impairment in quality of life Due to its chronic relapsing nature and limited long term safety of conventional immunosuppressive therapies there is a growing need for cost effective and holistic treatment modalities In Ayurveda palmoplantar psoriasis shows close clinical resemblance to Vipadika a Kshudra Kushtha characterized by pani pads sphutana tivra vedana kandu raga and pidika arising from tridosha vitiation with predominance of Vata and Kapha Classical Ayurvedic management of Kushtha emphasizes a combined systemic and local approach wherein Shamana Chikitsa and Bahiparimarjana Chikitsa play a pivotal role The concept of Yamaka Sneha the synergistic use of Ghrita and Taila is particularly advocated in Vipadika for its enhanced penetrability dosha pacification wound healing and immune modulatory effects The present study is designed as a single arm open label clinical trial to evaluate the efficacy of Nimbadi Capsule oral and Nimbadi Ghrita Lepam topical Yamaka Sneha formulation prepared from the classical Panchanimbaka formulation described in Gada Nigraha A total of 45 patients aged 18 to 60 years diagnosed with Vipadika or palmoplantar psoriasis will receive the intervention for 28 days Clinical assessment will be carried out using the Palmoplantar Psoriasis Area and Severity Index Dermatology Life Quality Index Visual Analogue Scale and subjective parameters The study aims to generate scientific evidence for the role of Ayurvedic therapy as effective and integrative approach in the management of palmoplantar psoriasis
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Age group between 18 to 60 years.
- •Patients with signs and symptoms of vipadika (palmoplantar psoriasis).
- •Patients will be selected irrespective of their gender, religion, occupation.
- •Patients willing to participate in the study, who give written consent.
排除标准
- •Pregnant, lactating women.
- •Patient suffering with severe systemic diseases like diabetes, cancer, guttate psoriasis, psoriasis present on the areas other than palms and feet, systemic infections like HIV, etc.
研究者
Dr Swarnima Amrutraj Mane Deshmukh
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta
