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1. A randomized, double blind, placebo controlled, multicenter clinical trial to assess the efficacy and safety of Emblica officinalis extract in patients with dyslipidemia. Background-Dyslipidemia is one of the most frequently implicated risk factors for development of atherosclerosis. This study evaluated the efficacy of amla (Emblica officinalis) extract (composed of polyphenols, triterpenoids, oils etc. as found in the fresh wild amla fruit) in patients with dyslipidemia. Methods-A total of 98 dyslipidemic patients were enrolled and divided into amla and placebo groups. Amla extract (500 mg) or a matching placebo capsule was administered twice daily for 12 weeks to the respective group of patients. The patients were followed up for 12 weeks and efficacy of study medication was assessed by analyzing lipid profile. Other parameters evaluated were apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), Coenzyme Q10 (CoQ10), high-sensitive C-reactive protein (hsCRP), fasting blood sugar (FBS), homocysteine and thyroid stimulating hormone (TSH). Results-In 12 weeks, the major lipids such as total cholesterol (TC) (p = 0.0003), triglyceride (TG) (p = 0.0003), low density lipoprotein cholesterol (LDL-C) (p = 0.0064) and very low density lipoprotein cholesterol (VLDL-C) (p = 0.0001) were significantly lower in amla group as compared to placebo group. Additionally, a 39% reduction in atherogenic index of the plasma (AIP) (p = 0.0177) was also noted in amla group. The ratio of Apo B to Apo A1 was reduced more (p = 0.0866) in the amla group as compared to the placebo. There was no significant change in CoQ10 level of amla (p = 0.2942) or placebo groups (p = 0.6744). Although there was a general trend of FBS reduction, the numbers of participants who may be classified as pre-diabetes and diabetes groups (FBS > 100 mg/dl) in the amla group were only 8. These results show that the amla extract used in the study is potentially a hypoglycaemic as well. However, this needs reconfirmation in a larger study. Conclusions-The Amla extract has shown significant potential in reducing TC and TG levels as well as lipid ratios, AIP and apoB/apo A-I in dyslipidemic persons and thus has scope to treat general as well as diabetic dyslipidemia. A single agent to reduce cholesterol as well as TG is rare. Cholesterol reduction is achieved without concomitant reduction of Co Q10, in contrast to what is observed with statins.[ Haridas Upadya, S. Prabhu, Aravinda Prasad, Deepa Subramanian, Swati Gupta & Ajay Goel BMC Complementary and Alternative Medicine volume 19, Article number: 27 (2019)]

2. Amlamax™ in the Management of Dyslipidemia in Humans. Hypercholesterolemia is the major cause of cardiovascular diseases leading to myocardial infractions leading to considerable morbidity and mortality. During the past decade a group of molecules referred to as statins such as simvastatin, atrovastatin have been tried with great success in reducing total cholesterol. These molecules act by inhibiting the HMG CoA reductase enzyme thereby interfering with the synthesis of cholesterol. But statins reduce all the cholesterol including HDL cholesterol. Long term drug vigilance activity has revealed serious side effects of tendinopathy and related musculoskeletal disorders in some of the subjects. In an effort to manage hypercholesterolemia without serious side effects in a natural way we had tried the use of Amlamax™ a reconstituted, purified, standardized dried extract of amla (Emblica officinalis) containing 30% ellagitannins significant elevation of HDL cholesterol by the administration of Amlamax™ [Antony B, Merina B, Sheeba, V. Amlamax™ in the Management of Dyslipidemia in Humans. Indian J Pharm Sci. 2008 Jul-Aug; 70(4): 504-507]

3. A Pilot Clinical Study to Evaluate the Effect of Emblica Officinalis Extract (Amlamax™) on Markers of Systemic Inflammation and Dyslipidemia. Emblica officinalis Gaertn, commonly known as the Indian gooseberry of “Amla”, has been used as 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 significant reduction in total cholesterol and triglycerides as well as increase in HDL. The present study extends these results to human volunteers. Two doses of the extract were evaluated – 500mg and 1000mg per day for 6 months. Blood samples were collected at the 3rd and 6th months showed 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 and 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 disease. [Antony B, Benny M, KaimalTNB. A Pilot Clinical Study to Evaluate the Effect of Emblica Officinalis Extract (Amlamax™) on Markers of Systemic Inflammation and Dyslipidemia. Indian Journal of Clinical Biochemistry. 2008; 23(4): 378-381.]

Animal Research

4. Effect of Standardized Amla Extract on Atherosclerosis and Dyslipidemia. Emblica officinalis, commonly known as Indian gooseberry (Amla), is found to be effective for the reversal of dyslipidemia and intima-media thickening and plaque formation in the aorta in hypercholesterolaemic rabbits. In this study, cholesterol powder (100 mg/kg body weight) was administered orally to healthy NZ white rabbits for 4 mo to induce hypercholesterolaemia; and thereafter, amla extract was given in two doses (10 mg and 20 mg/kg/ d orally) for 4 mo. Fasting lipid profile was done monthly and also at the end of treatment. After sacrificing the animals, tissue cholesterol (liver, heart and kidney) and 3-hydroxy-3-methylglutaryl-Coenzyme A reductase activity of liver were estimated and part of aorta and myocardium were processed for histological studies. Feeding of amla extract (10 mg and 20 mg/kg) for 4 mo reversed these changes and the lumen of the aorta became normal as in the normal control group. Reversal of dyslipidemia and atheromatous plaques achieved by amla extract seems to be brought about by a number of factors, such as its ability to prevent low-density lipoprotein oxidation, its antioxidant action, besides decreasing synthesis of cholesterol by inhibiting 3-hydroxy-3-methylglutaryl-Coenzyme A reductase activity and elevating high-density lipoprotein level to enhance reverse cholesterol transport. [Antony B, Merina B, Sheeba V, Mukkadan J. Effect of Standardized Amla Extract on Atherosclerosis and Dyslipidemia. Indian J Pharm Sci. July-August 2006; 68(4): 437-441.]

5. Toxicity Studies of Amlamax™ - Purified Standardized Extract of Emblica Officinalis. Amlamax™ is the purified, standardized extract of ‘Amla’ fruits. Acute and subacute toxicity studies were carried out by oral administration of Amlamax™ at different dosages in mice and rats. Doses up to 2g/kg orally for three months did not produce any haematological, biochemical and histological changes in vital organs. [Antony B, Merina B, Sheeba V. Toxicity Studies of Amlamax™ - Purified Standardized Extract of Emblica Officinalis. Indian J. Nat. Prod. 2007;23(2):14-17.]

Additional Research

6. Hypolipidemic Activity of Phyllanthus Emblica Linn (Amla) & Trigonella Foenum Graecum (Fenugreenk) Combination In Hypercholesterolemic Subjects – A Prospective, Randomised, Parallel, Open-Label, Positive Controlled Study. The present study is aimed at to evaluate the hypolipidemic and antioxidant activity of combination of fenugreek and amla in hyperlipidemic subjects.Twenty eight subjects were selected from outpatient department of medicine with the inclusion criteria of total cholesterol > 220mg/dl and or serum triglyceride >140mg/dl. They were enrolled for a period of 12 weeks after obtaining written informed consent. Subjects were randomly divided into 2 groups. Group I [test drug combination -1000mg Amla + 500mg Fenugreek/day] and Group II [standard drug Atorvastatin 10 mg daily]. Subjects were evaluated every 4 weeks for 12 weeks. During these visits biochemical investigations of lipid profile and antioxidant activity were done. At the end of 12 weeks, there were significant decrease in serum total cholesterol (20-26%), LDL (25-34%), triglyceride (15-30%) and VLDL (15-30%) levels & an increase in the HDL (0-5%) in the test drug group. This combination has shown similar response on lipid profile as statins with lesser adverse effects. Antioxidant activity of the combination is also demonstrated in the trial. [Joseph S, Santhost D, Udupa AL, Gupta S, Ojeh N, Rathnakar UP, et al. Hypolipidemic Activity of Phyllanthus Emblica Linn (Amla) & Trigonella Foenum Graecum (Fenugreek) Combination In Hypercholesterolemic Subjects – A Prospective, Randomised, Parallel, Open-Label, Positive Controlled Study. Asian Journal of Biochemical and Pharmaceutical Research. 2012;1(2):225-230.]

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