确定Sivanarvembu kuzhithailand治疗银屑病（Kalanjagapadai）安全性和有效性的随机对照研究方案

IF 1.9 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Ayurveda and Integrative Medicine Pub Date : 2025-09-01 DOI:10.1016/j.jaim.2025.101191

Rathinamala Rathinam , Gayathri Gunalan , Lavanya Alagusolaiyan , Vinu Bharathi Balasubramaniam , Rajendra Kumar Arumugam , Sathiyarajeswaran Parameswaran

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引用次数: 0

摘要

牛皮癣是一种慢性皮肤病，是一种严重的全球负担，影响着全球超过1亿人。常规治疗，包括局部和全身治疗，有其自身的局限性和副作用。悉达医学，深深植根于综合原则，提供了银屑病管理的另一种方法。本随机对照试验旨在探讨经典释迦药Sivanarvembu kuzhithailand治疗银屑病的安全性和有效性。目的：本RCT的主要目的是确定Sivanarvembu kuzhithailand （SVK）和Vetpalai thailand的安全性和有效性，并显着降低银屑病患者的PASI评分。次要目标包括验证研究参与者的生化变化，并确定治疗前后他们生活质量的提高。因此，在本临床试验中进行了特定的炎症标志物、蛋白质、抗氧化剂和氧化应激评估，以更深入地了解炎症程度、疾病严重程度和试验药物的作用机制。方法采用单中心、开放标签、平行组、探索性随机对照试验，样本量为90例，目的是确定Sivanarvembu kuzhithai治疗银屑病的安全性和有效性。本研究方案遵循SPIRIT 2013指南。结果主要观察指标为银屑病面积及严重程度指数（PASI）评分从基线到91天的减少情况及安全性参数。次要结果包括通过评估皮肤病生活质量指数来评估参与者生活质量的改善，以及检查试验参与者血液样本中的抗氧化水平、炎症标志物、生化标志物。结论本研究的结果可以外推到下一阶段的临床试验中，在更大的人群中为这种传统的Siddha配方的全球接受提供强有力的科学证据。

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A randomized controlled study protocol to determine the safety and efficacy of Sivanarvembu Kuzhithailam in the management of Psoriasis (Kalanjagapadai)

Background

Psoriasis is a chronic skin disorder with a substantial global burden, affecting over 100 million people worldwide. Conventional treatments, including topical and systemic therapies, have their own limitations and side effects. Siddha medicine, deeply rooted with comprehensive principles, offers an alternative approach in Psoriasis management. This randomized controlled trial aims to explore the safety and efficacy of Sivanarvembu Kuzhithailam, a classical Siddha medicine in the management of Psoriasis.

Objectives

The primary objective of this RCT is to determine the safety and efficacy of Sivanarvembu Kuzhithailam (SVK) and Vetpalai thailam and to reduce the PASI score in Psoriasis patients significantly. The secondary objective involves validating the biochemical changes in the study participants and determining enhancements in their quality of life before and after treatment. As a result, specific inflammatory markers, proteins, antioxidants, and assessments of oxidative stress have been undertaken in this clinical trial to provide deeper insights into the extent of inflammation, disease severity, and the mechanisms of action of the trial drug.

Methods

This is a single center, open-label, parallel group, exploratory randomized controlled trial with a sample size of 90 and with the objective of determining the safety and efficacy of Sivanarvembu Kuzhithailam in the management of psoriasis. This study protocol followed the SPIRIT 2013 guidelines.

Result

The primary outcome is to measure the reduction in the Psoriasis Area and Severity Index (PASI) score from baseline to 91 days and safety parameters. Secondary outcomes include the evaluation of enhancements in participants' quality of life through the assessment of the Dermatology Life Quality Index, as well as the examination of antioxidant levels, inflammatory markers, biochemical markers, in blood samples of trial participants.

Conclusion

The outcome of the study can be extrapolated to the next level of clinical trials with larger populations to provide robust scientific evidence for this traditional Siddha formulation for global acceptance.

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