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临床试验/CTRI/2025/03/082982
CTRI/2025/03/082982尚未招募3 期

Effect of Vamana karma or Virechana karma followed by Saptasama Gutika and Saptasama Gutika alone on the Antioxidant w.s.r. to Superoxide Dismutase in the management of Ekakushtha (Psoriasis) - An Open Labelled Randomized Comparative Clinical Trial

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
It is expected that the trial may Increase the level of Superoxide Dismutase levels.

研究概览

简要总结

Introduction:Skin disorders are collectively referred to as "Kushtha" in Ayurveda which are further divided into two main categories: Maha Kushtha (severe skin conditions) and Kshudra Kushtha (milder skin conditions). Ekakushtha falls under the category of Kshudra Kushtha. Ayurvedic texts classify all forms of Kushtha as manifestations of "Tridosha," indicating that they involve an imbalance of the three *doshas.*Psoriasis is compared with Ekakushtha because it aligns more closely with psoriasis than other types of Kushtha. The dosha-dushya (body humor and tissue) imbalance in Ekakushtha is characterized by a predominance of Vata and Kapha doshas.Psoriasis is exacerbated by Oxidative Stress.Superoxide Dismuatase constitute an important antioxidant defence against oxidative stress in the body.Significance:Psoriasis is a challenging problem globally. Near about 125 million people worldwide, 2 to 3% of total population have psoriasis, according to the World Psoriasis Day consortium. With a prevalence of 0.44-2.8% in India, it commonly affects individuals in their third or fourth decade with males being affected two times more common than females.

The primary treatment approach for Kustha involves frequent Sodhana procedures including Vamana and Virechana Procedures*. Saptasama Gutika* possesses Kusthaghna and Rasayana Properties. Till now no study has been reported on effect of Vamana Karma or Virechana Karma followed by Saptasama Gutika and Saptasama Gutika alone on the level of Superoxide dismutase in Ekakustha (Psoriasis).

Aim & Objectives:To evaluate and compare the Vamana Karma or Virechana Karma followed by Saptasama Gutika and Saptasama Gutika alone increase the level of Superoxide Dismutase in Ekakushtha (Psoriasis).Materials and Methods:30 Diagnosed and newly diagnosed Patients of Psoriasis will be enrolled in three groups.

Group A patients will receive intervention with Vamana karma Followed by Saptasama Gutika.

Group B patients will receive Virechana karma Followed by Saptasama Gutika.

Group C patients will recive saptasama Gutika alone.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Willing and able to participate in the study 2)Patient having sign and symptoms of Ekakushtha (Psoriasis) which are mentioned in diagnostic criteria 3)Chronicity of disease less than 10 years 4)Patients Yogya for Vamana Karma and Virechana Karma as per Ayurvedic classics.

排除标准

  • Age below 18 years and more than 60 years 2)Pregnant and lactating women 3)Chronicity of disease greater than 10 years 4)Uncontrolled D.M., HTN, Cancer, T.B., Heart disease 5)Patient Ayogya for Virechana Karma and Vamana Karma 6)Pustular type of psoriasis 7)Other concomitant skin disease occurring with Ekakushtha or allergic reaction of any other disease.

结局指标

主要结局

It is expected that the trial may Increase the level of Superoxide Dismutase levels.

时间窗: Group-A 45-48 Days | Group-B 45-50 Days | Group-C 45 Days

It may also provide relief in signs and symptoms of Ekakushtha (psoriasis).

时间窗: Group-A 45-48 Days | Group-B 45-50 Days | Group-C 45 Days

次要结局

  • Improvement in Psoriasis Area & Severity Index (PASI) score from baseline(Group-A 45-48 Days)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sameer Khan

Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat

研究点 (1)

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