Introduction: Fistula in ano is considered to be complicated and vicious due to its nature of recurrences and exacerbations. Ayurveda includes this disease under the list of AstaMahagada (eight serious diseases that are difficult to treat by nature itself) due to this attribute. Ayurvedic literature offers various effective and safe management strategies for fistula in ano. Several works have been conducted to prove the efficacy and effectiveness of various treatment modalities mentioned in Ayurvedic texts. Kshara sutra, Kshara karma, Agnikarma, and Ksharavarti are a few to name in this list. A lacuna exists in not analyzing or compiling these works. Hence, the purpose of this systematic review is to generate evidence for efficacy, effectiveness, and safety profile of Ayurvedic interventions in the management of fistula in ano.
Materials and methods: Electronic search from various online databases and clinical trial registers will be done. Manual search for gray literatures will be done from various colleges and universities. There will be no language restrictions. Three authors independently will screen all citations and abstracts to identify potentially eligible trials. Based on the inclusion criteria, full articles will be evaluated and disagreements will be discussed among the three authors. Data extraction from the included studies will be done by the three reviewers independently with extraction forms containing methods, participants, interventions, comparators/controls, and outcomes. Each of the included trials will be assessed for risk of bias. Primary data analysis will be done for both qualitative and quantitative data. Heterogeneity among trials will be assessed by inspecting forest plots. If heterogeneity is detected, and it is still considered clinically meaningful to combine studies, a random-effects model will be used. Meta-analysis will be done for pooled estimates and others would be presented as narrative synthesis and shall be represented in tabular and graphical forms.
Dissemination: The systematic review will be published in a peer-reviewed journal. It will also be disseminated electronically and in print. The review may guide healthcare practices and policy framing regarding the treatment of fistula in ano with Ayurvedic interventions.
Study registration: PROSPERO registration no. CRD42019131911.
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