A double-blind randomized placebo-controlled clinical study to evaluate the efficacy and safety of a polyherbal formulation in geriatric age group: A phase IV clinical report

Abstract

We sought to determine the efficacy as antioxidant and safety profile of the polyherbal formulation in geriatric patients of eastern India. The study was double-blind, randomized including placebo controlled and was approved by the ethical committee of SSKM hospital. Geriatric patients attending the OPD (outpatient department) of SSKM hospital formed the study group. The patients were randomized to receive either the polyherbal formulation or the identical-looking placebo at a dose of 2 tablets twice daily for a period of 6 months. Follow-up of patient status was done monthly. The clinical parameters were assessed before and after 6 months of medication or placebo intake. The results showed that significant rejuvenation of the anti-oxidant property which is determined by the enzymatic and non enzymatic anti oxidants, superoxide dismutase, catalase, glutathione peroxidase, glutathione reductase, reduced glutathione and malondialdehyde in the geriatric patients were seen in patients treated with Geriforte tablets as compared to patients treated with placebo and control group. There were no significant adverse effects experienced by cases in any group. Polyherbal formulation is effective in rejuvenating geriatric age group compared to the placebo. This formulation is safe and compliance to the treatment was good. In ancient Ayurveda the constituents of polyherbal formulation were prescribed for different diseases including cardiological, neurological, sepsis, etc.