Clinical Evaluation of Efficacy and Safety of Classical Ayurveda Formulations, Panchatikta Ghrita and Nalpamaradi Taila, in the Management of Psoriasis

Abstract

Background: Psoriasis is a common immune-mediated dermatological manifestation that has a significant impact on the physical, social, and psychological well-being of the individual. The most common cutaneous manifestation of the disease includes chronic, symmetrical, scaling papules, and plaques on an erythematous base. Ayurveda considers skin disorders under the spectrum of Kushta and those diseases that manifest with dryness, exfoliation, thick plaques, etc., are generally attributed to vitiation of Vata and Kapha Dosha with underlying Rakta Dhatu Dushti. Panchatikta Ghrita has been used for both Shodhanartha Snehapana (oleation for Shodhana purpose) and Shamana in skin diseases of varied origin. Nalpamaradi Taila is ideal in vitiation of Vata and Kapha Dosha while pacifying Pitta and Rakta Dushti. Materials and methods: A multicenter, open-label prospective study that is to be executed at two Institutes of Central Council for Research in Ayurvedic Sciences (CCRAS) which were dedicated to research of skin disorders. A total of 120 patients would be recruited for the trial (60 from each institute) and would be administered with Panchatikta Ghrita in the dose of 6 g twice daily before food, with lukewarm water as Anupana, while Nalpamaradi Taila will be given for external application over the affected areas twice daily for a duration of 12 weeks. The primary outcome will be change in psoriasis area and severity index (PASI) score from baseline to final visit and change in dermatology life quality index (DLQI) questionnaire will be the secondary outcome measure. The safety and tolerability of the formulations will be determined by clinical/biochemical assessments during the follow-ups. Paired t test would be used to assess the efficacy of the interventions at 12th and 14th week when compared with the baseline. Data will be collected and analyzed at CCRAS Headquarters using SPSS 15.0 software. Ethics and dissemination: Ethics approval has been obtained from the participating institutes. The results obtained will be submitted for publication in a peer-reviewed journal.