A multicentric, double-blind, randomized, placebo-controlled clinical study to evaluate the novel combination of Taurine and Ginseng in improving energy parameters in healthy male subjects
Main Article Content
Abstract
Objective: To evaluate the efficacy and safety of the multivitamin tablet “Health OK” (phytochemical formulation of nutrients and super-nutrients like Taurine and Ginseng Extract) in healthy male subjects.
Material and methods: This was a multicentric, double-blind, randomized, placebo-controlled clinical study of Health OK Tablet (Multivitamin, Multimineral, Amino Acids with Taurine & Ginseng Extract) (test product:control= 2:1). Efficacy parameter evaluation was carried out at randomization, and follow-ups (2, 4, 8 and 12th weeks). Primary endpoint was to assess general well-being. Secondary endpoints were mean changes in laboratory parameters, immune/inflammatory response, oxidative stress markers, energy and fatigue, mental alertness, and memory.
Results: 56.67% of the 60 test subjects showed clinical improvement in general well-being compared to 30% in control. The test group showed notable improvement in the Energy and Fatigue scores by day 14, than control group. Similar differences between the two groups were also observed in mental alertness and memory scores. In terms of the immune/inflammatory response, the test group (2.58 pg/ml) showed a major reduction in IFN-γ from baseline to the end of the study (EOS) than the control group (1.5 pg/ml). Significant reductions were seen in levels of malondialdehyde (p=0.0001), superoxide dismutase (p=0.0261), and glutathione (p=0.0058) in the test group than control. None of the subjects were withdrawn from the study owing to adverse events.
Conclusion: Our results showed that the test product was effective in improving the general well-being, energy, memory and mental alertness parameters, immune and inflammatory responses and oxidative stress markers compared to placebo in healthy male subjects, with improvement in energy scores evident within 14 days.
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