Comparative evaluation of indigenous aromatherapy and nicotine replacement therapy for nicotine dependence among transgender women in Puducherry: a randomized controlled trial

Background Evidence on tobacco cessation interventions among transgender women in India remains limited. Aromatherapy has been explored as a complementary, non-pharmacological approach for managing tobacco cravings and withdrawal-related symptoms, but comparative evidence with established pharmacological treatment is limited.Objective To compare the effectiveness of indigenous aromatherapy and nicotine replacement therapy (NRT) in reducing nicotine dependence among transgender women in Puducherry.Methods A parallel-group randomized controlled trial was conducted among 50 transgender women who were current tobacco users and willing to reduce or quit tobacco use. Participants were randomly allocated in a 1:1 ratio to receive indigenous aromatherapy or NRT, along with standardized behavioral counseling. Nicotine dependence was assessed using the Fagerström Test for Nicotine Dependence (FTND) at baseline, 45 days, and 3 months. Between-group differences were assessed using the Mann–Whitney U test, while within-group changes were assessed using the Friedman test.Results Twenty-five participants were allocated to each group. No significant between-group differences in FTND scores were observed at baseline (5.68 vs. 6.00; p = .216), 45 days (4.88 vs. 5.32; p = .155), or 3 months (4.60 vs. 4.56; p = .958). FTND scores decreased significantly over time in both the NRT (p = .002) and aromatherapy (p < .001) groups.Conclusion Both interventions were associated with reduced nicotine dependence over time; however, indigenous aromatherapy did not demonstrate superiority over NRT. Larger trials with longer follow-up are warranted.