Background: Emblica officinalis Gaertn., commonly known as the Indian gooseberry or “Amla”, has been used as a health food for centuries in India and other Asian countries. The biological effects of amla have been attributed to the antioxidant properties of the low-molecular-weight hydrolysable tannins present in the fruit. Amlamax™ is a purified, standardized, dried extract of amla containing about 35% galloellagi tannins along with other hydrolysable tannins. Our earlier studies on rabbits showed a significant reduction in total cholesterol and triglycerides as well as an increase in HDL. The present study extends these results to human volunteers. Two doses of the extract were evaluated – 500 mg and 1000 mg per day for 6 months. Blood samples were collected at the 3rd and 6th months showed a reduction in total and LDL cholesterols and enhancement of beneficial HDL cholesterol. In addition, blood CRP levels, a marker for inflammation, were also significantly reduced. Since dyslipidemia and inflammation are the two major components of cardiovascular diseases, the present results must be considered encouraging and indicate the potential of Amlamax™ in the management of heart diseases.

Introduction: Amla (Emblica officinalis), commonly known as Indian gooseberry is widely used in many of the indigenous medical preparations against a variety of disease conditions. In vitro and animal studies have indicated that amla has a potent anti-oxidant effect against several test systems such as superoxide radicals, lipid peroxide formation induction by Fe+++/ADP ascorbate system, hydroxyl radical scavenging action and in systemic augmentation of antioxidant enzymes in the brain of laboratory animals. In rats, the flavonoids from E. officinalis effectively reduced lipid levels in serum and tissues and exerted a significant inhibitory effect of hepatic HMG CoA reductase enzyme activity. Our earlier study showed the beneficial effects of AmlamaxTM on atherosclerosis and dyslipidemia in rabbits. The antioxidant activity of fruits of E. officinalis has been traced to its tannoid principles both in vitro and in vivo. A study conducted in rats found that gallo ellagi tannins enriched fractions of fresh juice of Emblica fruits showed antioxidant activity in ischemia – reperfusion-induced oxidative stress in rat heart. The aqueous extract of E. officinalis fruit increases cardiac glycogen levels and decreases serum GOT, GPT and LDL in rats having induced myocardial necrosis. Elevation of HDL as first observed in our study on rabbits is a significant result obtained with AmlamaxTM for which a patent application is under processing. AmlamaxTM was found to be nontoxic in both acute and subacute toxicity studies in rats up to a dose of 2g/kg for three months.

Methods: Fresh fruits of amla (Emblica officinalis) (250 kg) were cleaned, crushed, deseeded and refluxed with water for 2 hours. Then it was cooled and filtered. The filtrate was collected and the residue was extracted with water. The combined filtrates were pooled and concentrated at 90°C under vacuum. The dried powdered extract was collected (yield – 4.6%). This crude extract was analyzed for total polyphenols, proteins and galloellagi tannins. This standardized extract (AmlamaxTM) was made into 500mg tablets which were used for the study.

Results: The results show that treatment with Amlamax at doses of 500 mg/day and 1000 mg/day brought about a significant reduction in the level of risk factors of CVD arising from dyslipidemia and inflammation. Considering that presently no therapeutic options are available that specifically targets inflammation in atherosclerosis, the results of AmlamaxTM should be considered significant. The safety of the product is an added feature. A well-controlled, randomized study is warranted.

Conclusions: The mechanisms by which AmlamaxTM exerted the beneficial effects is presently not clear. Amla, like statins, is credited with HMG CoA reductase inhibitory activity. Ellagitannins and the ellagic acid obtained on hydrolysis of these tannins (by lipases and/or esterases) are inhibitors of squalene epoxidase, a rate-limiting enzyme of cholesterol biosynthesis. These inhibitory activities may explain the beneficial effects of Amlamax on lipid parameters. Inflammation/infection is known to reduce HDL levels and the enhancement