Comparative Effectiveness of Trinpanchmula Ghanvati with Shveta Parpati in the Management of Pittaja Mutrakriccha (UTI) - Study Protocol for an Open Labelled Randomized Controlled Trial

Background- Ayurvedic literature delineates a comprehensive approach for the management of PittajaMutrakriccha, encompassing the administration of herbo-mineral formulations, adoption of therapeutic yogic interventions, and implementation of appropriate lifestyle modifications. The purpose of this study is to compare the efficacy of TrinpanchmulaGhanvati with Shveta Parpati in the treatment of PittajaMutrakriccha patients. Although plenty of formulations are there, but there is no research work done to proof the efficacy of TrinpanchmulaGhanvati in the management of PittajaMutrakriccha. Methodsanddesign- In a prospective, open labelled, randomized controlled trial, 60 patients, between 18 and 50 years, diagnosed with Pittaja Mutrakriccha, presenting with cardinal features of PittajaMutrakriccha as described in Ayurvedic texts, two groups will be randomly assigned. In Group one, the patients will receive TrinpanchmulaGhanvati and in Group two, patients will receive Shveta Parpati. Guidelines regarding Pathya-apathya will be given to both the groups. The course of treatment will last for 14 days for both groups. Outcomes will be evaluated on 7th, 14th (During treatment) & 21st& 28th (post-treatment). Result: The primary outcome will be assessed by checking the grading of the cardinal symptoms of PittajaMutrakriccha mentioned in Ayurvedic texts. Secondary outcome will check for improvement in laboratory investigations and quality of life of the patient. Conclusion: This trial is first to compares the effectiveness of TrinpanchmulaGhanvati with Shveta Parpati in the patients of PittajaMutrakriccha. TrinpanchmulaGhanvati is envisioned to improve the symptoms of PittajaMutrakriccha, thus proving to be effective in management of patients of PittajaMutrakriccha