ACTIVO-I Study Report - A Retrospective Prescription Event Monitoring for Safety and Efficacy of Waist Circumference in the Management of Overweight and Obesity.

ABSTRACT

The study was conducted on the combination of bioactive ingredients [Bioactives; Hoodia Gordonii, Hydroxycitric Acid (the active ingredient in Garcinia cambogia), Green tea extract, Ginger extract and Piperine] to estimate its safety and efficacy in decreasing the body weight (BW), body mass index (BMI) and waist circumference (WC) after treatment. Design and methods: The study was retrospective prescription event monitoring study. Total 99 overweight and obese patients (52 males and 47 females; mean age 45.45 ± 10.20 years) were enrolled in the study. Subjects were administered one capsule of Bioactives orally one hour before lunch and dinner daily for 90 days. All subjects were given standard advice regarding healthy food choices in their diet and physical activity. However, subjects were not advised to restrict dietary calorie intake. Clinical examination, BW, BMI and WC were estimated in all subjects at baseline and at the end of 30, 60 and 90 days. Observations Bioactives was found to be significantly effective in decreasing BW by 4.36%, 7.12 % and 10.25% at 30, 60 and 90 days respectively and these results were statistically significant (p = 0.002, p <0.0001 and p <0.0001 respectively). BMI was also reduced with Bioactives by 5.11%, 9.83% and 11.88% at 30, 60 and 90 days respectively and results were statistically significant (p <0.0001, p <0.0001 and p <0.0001 respectively). Bioactives was found to be significantly effective in decreasing WC by 3.28%, 5.29% and 7.31% at 30, 60 and 90 days respectively and these results were statistically significant (p = 0.0023, p <0.0001 and p <0.0001 respectively). Bioactives can be rated as good to very good based on results observed on 66% patients. Side effect or adverse event was not reported in any case. Conclusion: Bioactives appears to be significantly effective in decreasing the BW, BMI and WC within 30, 60 and 90 days in overweight and obese patients. Bioactives has excellent tolerability as adverse event was not reported in any case.