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.