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Journal of Research in Ayurvedic Sciences 2019 January- March ; 3 (1) :27-33
A Study Protocol of a Prospective, Open-label, Single-arm, Clinical Trial to Evaluate the Efficacy of Classical Ayurveda Medicines in the Management of Vicharchika (Atopic Eczema)

Abstract
Background: In Ayurveda, Vicharchika (atopic eczema, AE) has been discussed under the heading of Kshudra kustha. It is a variety of inflammatory skin disorders diagnosed as a chronic, widespread, noninfective inflammatory condition that causes severe pruritus, erythema with variable degree of exudates and scaling, which can impact at any age. The etiology of AE is complex and not fully understood. Although the traditional Ayurveda medicine is used as an alternative therapy for AE, available evidence relating to its effectiveness and mechanism are not fully implicit. Hence, a protocol of a prospective, multicenter, single-arm, open-label clinical trial using traditional Ayurveda medicine to investigate the effectiveness, mechanism, and safety for patients with Vicharchika (eczema) is being reported. Materials and methods: This is a multicenter, single-arm, open-label clinical trial to evaluate the safety and efficacy of traditional Ayurveda formulations Panchatikta Ghrita and Nalpamaradi Taila in the management of Vicharchika (eczema). A total of 120 patients with Vicharchika (eczema) will be selected based on the inclusion and exclusion criteria. All the patients will be provided with classical Ayurvedic formulation, i.e., Panchatikta Ghrita 6 g orally twice daily before food and oil Nalpamaradi Taila 20 mL twice daily externally on the affected skin. Each participant will undergo a 12-week treatment period and a follow-up after 4 weeks. A total of seven visits will be scheduled for each participant: 1 visit each in week 0, week 2, week 4, week 6, week 8, week 10, and week 12. The primary outcome will be measured by the assessment of change in eczema area severity index (EASI) score before and after the recommended therapy. The secondary outcomes will be measured by—changes in clinical sign and symptoms per the Ayurvedic classics; changes in patient-oriented eczema measure (POEM) and changes in dermatology life quality index (DLQI) questionnaire. Therapeutic mechanism outcomes, safety outcomes, and end point outcomes will also be assessed. Discussion: Protocol was designed with projected outcome as better clinical deliverables and safety profile in Vicharchika patients and reduced relapse rate of disease during post treatment period. If found effective, the selected drug will be listed in the management protocol of Vicharchika at clinical practice level in terms of better efficacy, safety, and cost-effective treatment. The selected drug may lead to a step ahead of better understanding and management of additional skin disorders. Trial registration: Trial has been registered under clinical trials registry-India (CTRI); the registration number for this trial is CTRI/2019/12/022236. Keywords: Ayurveda, Nalpamaradi taila, Panchatikta ghrita, Protocol, Vicharchika

DHARA ID: D059613


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