TY - JOUR
T1 - A double-blind randomized placebo-controlled clinical study to evaluate the efficacy and safety of a polyherbal formulation in geriatric age group
T2 - A phase IV clinical report
AU - Banerjee, Payel
AU - Maity, Soumya
AU - Das, Tapas
AU - Mazumder, Santasree
N1 - Funding Information:
We acknowledge with thanks Himalaya Drug Company for funding the clinical trial and University Grants Commission for providing infrastructural support. The authors thank all members of the Department of Biochemistry, C.A.S. (Centre for Advance Studies), University of Calcutta and S.S.K.M & I.P.G.M.E.R, Kolkata for providing research support.
PY - 2011/3/24
Y1 - 2011/3/24
N2 - Aim of the study: We sought to determine the efficacy as antioxidant and safety profile of the polyherbal formulation in geriatric patients of eastern India. Materials and methods: 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. Results: 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. Conclusion: 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.
AB - Aim of the study: We sought to determine the efficacy as antioxidant and safety profile of the polyherbal formulation in geriatric patients of eastern India. Materials and methods: 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. Results: 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. Conclusion: 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.
KW - Antioxidants
KW - Ayurveda
KW - Geriatric patients
KW - Polyherbal formulation
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U2 - 10.1016/j.jep.2010.12.044
DO - 10.1016/j.jep.2010.12.044
M3 - Article
C2 - 21211560
AN - SCOPUS:79952695962
SN - 0378-8741
VL - 134
SP - 429
EP - 433
JO - Journal of Ethnopharmacology
JF - Journal of Ethnopharmacology
IS - 2
ER -