A Randomized single blind controlled clinical trial on safety and efficacy of a Unani formulation (Itrifal-e-Sagheer) in dyslipidemia

Aim:‘Itrifal-e-Sagheer’, a compound Unani formulation has been indicated in disease conditions simulating dyslipidemia. The present study was done to substantiate the efficacy of ‘Itrifal-e-Sagheer’ in dyslipidemia on scientific parameters. Materials and methods: A randomized, single blind, controlled, clinical trial was carried out on 30 patients of dyslipidemia who were randomly allocated into test (n = 15) or control (n = 15) groups. The test drug, Itrifal-e-Sagheer and control drug, Abana® were given to respective group for 45 days along with lifestyle modification. Results: The test drug significantly alleviated the symptoms of subjective parameters (palpitation, breathlessness and weight gain) (p<0.05). There was statistically significant reduction in lipid profile of the patients in test group (p<0.05) than control drug treatment. Conclusion: The study evidenced that Itrifal-e-Sagheer is potentially effective and safe in the treatment of dyslipidemia. However, a multicentric study with robust study design is required to generalize the results.