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临床试验/CTRI/2026/02/104433
CTRI/2026/02/104433尚未招募2/3 期

Single Arm Open Label Clincal Trial of Nimbadi Ghrita Lepam and Nimbadi Capsule in Vipadika (Palmoplantar Psoriasis)

Dr Swarnima Amrutraj Mane Deshmukh1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年3月15日最近更新:

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

发起方
Dr Swarnima Amrutraj Mane Deshmukh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Swarnima Amrutraj Mane Deshmukh

Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta

研究点 (1)

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