Effectiveness of Siddha poly herbal formulation (pugaiyilai nanju murivu kudineer) in tabacco de addiction a pilot study in tobacco deaddiction - A Pilot study

Upon approval from the Institutional Ethics Committee (IEC) and registration with the Clinical Trials Registry - India (CTRI), screening of potential participants will commence using a Screening Proforma. Eligible individuals will be enrolled after providing informed consent, During the baseline visit, participants will undergo a comprehensive clinical examination and history-taking,  Additionally, urine critinine levels will be measured using test kits to assess tobacco exposure. Lung function will be evaluated through Pulmonary Function Tests (PFT), and basic laboratory investigations (Form-III) such as Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR), Blood Sugar levels, Liver Function Tests (LFT), Renal Function Tests (RFT), Lipid Profile, and C-Reactive Protein (CRP) will be conducted. Chest expansion will be measured by assessing chest circumference. Participants daily cigarette consumption will be recorded at 15-day intervals, and the intensity of nicotine addiction will be assessed using the Fagerström Test for Nicotine Dependence (FTND) on a fortnight basis. Upon completion of the study period, all baseline assessments will be repeated. urine samples will be analyzed. Any adverse events will be recorded, irrespective of the relationship to the study intervention. In case of any serious adverse events, the intervention will be immediately discontinued and will be reported to pharmacovigilance centre.