Study Protocol for a Case Control Evaluation of Ajirna in relation to Metabolic Syndrome

Background: Metabolic Syndrome (MetS) is a cluster of conditions including abdominal obesity, dyslipidaemia, hypertension, and hyperglycaemia that collectively increase the risk of cardiovascular disease and type 2 diabetes mellitus. The prevalence of MetS in India is rising rapidly due to lifestyle transitions, dietary patterns, and reduced physical activity. From an Ayurvedic perspective, Ajirna (indigestion) and Ama (improper digested material) are considered root causes of numerous metabolic disorders. The conceptual correlation between Ajirna and MetS remains underexplored.

Objective: To establish an association between Ajirna and Metabolic Syndrome through a case-control analytical study. 

Materials and Methods: This retrospective case-control study will be conducted among 400 participants (200 cases and 200 controls), aged 30–60 years, at ITRA, Jamnagar. Cases will be diagnosed as per NCEP ATP III criteria, fulfilling at least three components of MetS. Age- and gender-matched healthy individuals will serve as controls. Data will be collected using a validated, close-ended questionnaire covering causative factors of Ajirna, Sthaulya (Obesity), Rasavaha Srotodushti, Medovaha Srtodushti and other lifestyle factors. Laboratory investigations will include Fasting Blood Sugar, lipid profile, liver and renal function tests. Statistical analysis will be performed using the Chi-square test to evaluate association and risk ratio to quantify magnitude of Nidan.

Outcome Measures: This study aims to explore a statistically significant association between Ajirna and MetS, thereby elucidating the role of digestive impairment in manifestation of Metabolic Syndrome.

Ethics: Ethical approval has been taken from the Institutional Ethics Committee following which recruitment commenced in October 2025.

Clinical Trial Registration:  CTRI/2025/05/086816 dated 13.05.2025