the mature roots of these plants are used in many traditional medical formulations to treat several different conditions . it has been used for more than 2000 years in asia as a traditional medicine and dietary supplement . the primary active constituents of ginseng are thought to be the ginsenosides , which include more than 20 saponin triterpenes similar in structure to steroid hormones . these are believed to act via hormone receptors in the hypothalamus , pituitary glands , and other hormone sensitive tissues . ginsenosides stimulate secretion of adrenocorticotropic hormone , leading to production of increased release of adrenal hormones , including cortisol . ginsenosides have also been reported to stimulate ribonucleic acid ( rna ) transcription , protein synthesis , and hepatic cholesterol production . in addition , they may stimulate synthesis of adrenal hormone precursors . according to recent studies , a hypolipidemic effect of panax ginseng extract ( pge ) is associated with decrease in total cholesterol ( tc ) , triglycerides ( tgs ) , low - density lipoprotein ( ldl ) , muscular dystrophy association ( mda ) levels and an increase in high - density lipoprotein ( hdl ) level . administration of pge increased serum superoxide dismutase ( sod ) and catalase ( cat ) activities while decreased mda level indicating that antioxidant potential of pge might induce hypolipidemic effect as one of action mechanism . ginseng lowers cortisol levels in individuals with diabetes , while increasing cortisol levels in non - diabetic individuals . specific triterpenoid saponins ( diols ) are claimed to cause improvements in endurance and learning . a second group ( trials ) has been reported to increases blood pressure and function as central nervous system stimulants . ginsenosides have carbohydrate - sparing actions and may increase muscle endurance . the effects of p. ginseng p. ginseng has also been reported to reduce weight loss and stabilize white blood cell counts during chemotherapy and to accelerate postsurgical recovery . many reports from clinical and experimental studies suggested that ginseng may have beneficial effects on reducing serum tc level and enhancing antioxidant status . however , ismail et al . reported that a ginseng extract ( g-115 ) had no significant hypolipidemic or antioxidant effects in rabbits . ginsenosides , have been known for the anti - inflammatory and anti - proliferative activities by significant inhibitory effect on tumor necrosis factor - alpha . the most extensively studied biomarker of inflammation in cardiovascular diseases is c - reactive protein ( crp ) , for which standardized high - sensitivity assays ( hs - crp ) are widely available . according to conflicting results from previous studies regarding the efficacy of ginseng on lipid profile and anti - inflammatory and anti - proliferative activities of its components , we aimed to evaluate the effects of p. ginseng on lipid profile , pro - oxidant  anti - oxidant status and hs - crp level . this study was conducted as a double - blind randomized controlled trial . for the proposed study , to achieve a similar difference between the ginseng extract and placebo treatment groups with an 80% power and confidence interval of 95% , it is estimated that a sample size of 15 subjects per group will be required , that is , 30 in total . the sample size was calculated according to the previous study of kim , et al . the inclusion and exclusion criteria were defined according to the american college of cardiology ( acc ) /the american heart association ( aha ) guidelines . the inclusion criteria were : ( 1 ) serum ldl - cholesterol ( ldl - c ) level 160 - 190 mg / dl in patients with 0 - 1 cardiovascular risk factors , ( 2 ) serum ldl - c level 130 - 160 mg / dl in patients with > 1 cardiovascular risk factors and < 10% coronary heart disease ( chd ) risk at 10 years according to framingham risk scores , ( 3 ) serum ldl - c level 100 - 130 mg / dl in patients with chd equivalent risk factors and > 20% chd risk at 10 years according to framingham risk scores , ( 4 ) tg level < 200 mg / dl , ( 5 ) age > 20 years . the exclusion criteria were : ( 1 ) overt hyperlipidemia requiring medical treatment ( serum ldl - c level > 190 mg / dl , tg level < 200 mg / dl ) ; ( 2 ) past history of diabetes mellitus or fasting blood glucose level > 126 mg / dl ; ( 3 ) past history of documented cardiovascular disease ; ( 4 ) pregnancy and lactation ; ( 5 ) past history of renal failure or glomerular filtration rate < 60 ml / min ; ( 6 ) acute infection , ( 7 ) active bleeding with the exception of menses , ( 8) taking anticoagulant ; ( 9 ) psychosis or anxiety disorder ; ( 10 ) mono amino oxidase inhibitors . of the total of 40 patients recruited and randomized to group , 20 participants were assigned to the placebo group , and 20 to the ginseng group . patients visited the clinic over a period of 8 weeks at three stages ( 0 , 1 , and 2 ) . at each clinic visit , height , weight , and body mass index ( bmi ) were measured for each participant . after allowing participants to rest for a minimum of 10 min , systolic and diastolic blood pressures were measured twice , and the averages were obtained . at stages 0 and 2 , blood sampling and biochemical evaluation were undertaken . at stages 0 and 1 , patients were administered the drug , or placebo [ figure 1 ] . for all the patients , we recommended the same diet according to acc / aha guidelines before intervention . study design and patient allocation design chart blood sampling was obtained before and after the 8 weeks drug / placebo administration . we choose an 8 week period according to the previous study of kim et al . after 12 h of fasting 10 ml of blood was collected from each patient . out of 10 ml , 5 ml of blood was collected into chilled tubes containing citrate and the rest into plain chilled tubes to obtain serum . , serum and plasma were frozen in dry ice prior to being stored at 80c . blood samples were used for estimation of tc , tg , ldl - c , hdl - cholesterol ( hdl - c ) , fasting blood glucose , serum creatinine and hs - crp . pro - oxidants - anti - oxidants balance ( pab ) assay was performed according to alamdari dh et al . method . the standard solutions were prepared by mixing varying proportions ( 0 - 100% ) of 1 mm hydrogen peroxide with 6 mm uric acid ( in 10 mm naoh ) . the following standard solutions were prepared separately : vitamin c ( 0 - 800 mm ) , trolox ( 0 - 800 mm ) , uric acid ( 0 - 6 mm in 10 mm naoh ) , glutathione ( 0 - 2500 mm ) , albumin ( 0 - 1000 mm [ 68 g / l ] ) , hydrogen peroxide ( 0 - 1000 mm ) and tert - buthylhydroperoxide ( 0 - 1000 mm ) . tetramethylbenzidine ( tmb ) solution was prepared by dissolving one tmb tablet in 10 ml of substrate buffer ( 0.05 mm phosphate citrate buffer , ph 5 ) . for preparation of tmb cation , 18 ml of fresh chloramine t ( 10 mm ) solution was added to 1 ml of tmb solution , incubated for 20 min ; and 1.25 u of peroxidase enzyme solution was added to 9 ml of tmb solution . the working solution was prepared by mixing the two latter solutions , incubated for 5 min at room temperature and used immediately ; 10 ml of each sample , standard or blank ( distilled water ) was mixed with 200 ml of working solution , in each well of a 96-well plate , which was then incubated in a dark place for 12 min at room temperature ; at the end of the incubation time , 100 ml of 2n hcl was added to each well . the plate was then incubated for 45 min in a dark place and measured in an elisa reader at 450 nm with a reference wavelength of 620 nm or 570 nm . the values of the pab are expressed in arbitrary units , which are the percentage of hydrogen peroxide in the standard solution multiplied by 6 . the values of the unknown samples were then calculated based on the values obtained from the above standard curve . tc , tgs and hdl - c were measured using a standard enzymatic method by biosystem kits and using an auto analyzer ( bt 3000 model ) . ldl - c was calculated by friedwald equation : ldl - c = tc - ( tg/5 + hdl - c ) . we measured fbs and serum creatinine using standard methods by biosystem commercial kit with auto analyzer bt3000 . each capsule contained 250 mg of ginseng extract , that contained 7 mg of ginsenosides and the components were characterized as follows : 2 - 3% for ginsenosides ( rb1 , rb2 , rb3 , rc , rd , re , rg1 ) , panacene , beta sitosterol , low molecular weight polysaccharides , flavonoids . ginsenosides or panaxosides are a class of steroid glycosides , and triterpene saponins , found exclusively in the plant genus panax ginseng . ginsenoside - rc is a steroid molecule that can be found in the ginseng plant and is recognized for producing more sedative related results than other ginsenosides , such as ginsenoside - re or ginsenoside - rg . rg1 appears to be most abundant in p. ginseng ( chinese / korean ginseng ) . the active ( ginseng ) group took two capsules twice a day for 8 weeks . the placebo was prepared in an industrial laboratory of the school of pharmacy at masshad university medical school . we used a granular powder included lactose ( 66% ) , starch ( 33% ) and magnesium stearate ( 1% ) as a placebo . an independent t test was used to compare changes from baseline to 8 weeks between the two groups . in addition , a paired t test was used to compare baseline data with changes at 8 weeks for each group . the repeated measure anova test mann - whitney and chi - squared tests were used to compare ordinal and nominal qualitative variables , respectively . p < 0.05 was considered significant for all data analyses . the study , which was conducted according to the declaration of helsinki , was approved by the mashhad university of medical sciences ethics committee and all participants gave written informed consent . two participants in the control and one participant in the case group dropped out of the study because of failure to follow the protocol . one patient in the case group dropped out of study due to abnormal liver function test results . this did not have effect the power of the study substantially because we overestimate the sample size . there was no significant difference between the two groups with respect to the occurrence of side effects ( loss of appetite , diarrhea , headache , blurred vision , insomnia , agitation , rashes and bleeding ) . table 1 , shows the changes in bmi , creatinine , and fasting blood sugar from baseline to week 8 [ table 1 ] . changes in body mass index , creatinine , fasting blood sugar from baseline to week 8 at the beginning of the study , there was no significant difference between the two groups regarding tc level . after 8 weeks of treatment , the serum tc level in the ginseng group decreased from 225.62  44.41 mg however , there was no significant difference between the two groups with respect to the change in serum tc level [ table 2 ] . changes in lipid profiles from baseline to week 8 there were no significant differences between the two groups regarding tg , ldl - c , hdl - c , tc / hdl - c levels , at the beginning of study . after 8 weeks of treatment , the serum tg , ldl - c , hdl - c , tc / hdl - c levels in the ginseng group decreased from 147.31  93.54 mg / l , 41.5  9.77 , 4.5  0.64 mg / l ( p < 0.006 , 0.0001 , 0.173 , 0.0001 ) , respectively . however , there were no significant differences between the two groups with respect to the change in serum tg , ldl - c , hdl - c and tc / hdl - c levels [ table 2 ] . there were no significant differences between the two groups with respect to changes in serum hs - crp and pab from baseline to week 8 [ table 3 ] . changes in high - sensitivity c - reactive protein , pro - oxidant - anti - oxidant balance from baseline to week 8 our study was a randomized double blind controlled trial , which aimed to determine the effects of ginseng root extract on lipid profile , hs - crp and pab . in the current study , 40 patients were recruited . one patient in the ginseng group dropped out of study due to abnormal liver function test results . no major side effects were detected , except the elevation of liver enzymes in one patient . after 1 month , one patient was found to have aminotransferase level more than twice the upper limit of normal . surprisingly , gastrointestinal side - effects were more prevalent in the placebo group , but this was not statistically significant . overall , no statistically significant difference was detected between the case and control groups regarding side - effects . according to kim et al . however , in our study , administration of ginseng had no significant effects on bmi and fat mass during the same period of treatment in addition , the dosage of pge in our study was lower than kim study . baseline demographic characteristics , lipid profiles , hs - crp , creatinine level , fasting blood glucose were not significantly different between the two groups . in our study , administration of ginseng significantly reduced tc , ldl - c , tg , tc / hdl - c levels during the period of study ; however , there were no significant difference between the two groups with respect to the same effect . kim et al . conducted a study that was not randomized and did not have control group . in this study , administration of ginseng at the dose of 8 g / day , reduced lipid levels . in sotaniemi study , tg level decreased and hdl - c level increased after administration of 100-mg and 200-mg doses of ginseng but these effects were not statistically significant . the sample size and study duration and ginseng dosage is similar to that used in our study . in the study of zuin et al . , administration of a 40-mg dose of ginseng twice daily , had no effect on lipid profile . the duration of this study was longer than ours and the sample size was similar to our study . experimental and clinical evidences accumulated since 1990 have established inflammatory processes as important contributors to atherogenesis , as well as to the vulnerability of an atherosclerotic lesion to rupture or erosion . based upon this evidence , protein markers of inflammation have been studied as non - invasive indicator of underlying atherosclerosis in apparently healthy individuals and of the risk of recurrent events in patients with established atherosclerotic vascular disease . crp is an acute phase protein that is produced predominantly by hepatocytes under the influence of cytokines such as interleukin-6 and tumor necrosis factor - alpha . data from more than 30 epidemiologic studies have shown a significant association between elevated serum or plasma concentrations of crp and the prevalence of underlying atherosclerosis , the risk of recurrent cardiovascular events among patients with established disease , and the incidence of first cardiovascular events among individuals at risk for atherosclerosis . ginsenosides , have been known for their anti - inflammatory and anti - proliferative activities by significant inhibitory effect on tumor necrosis factor - alpha , in vivo . according to this evidence , we evaluated the correlation between administration of ginseng and the level of hs - crp . our results showed no significant difference between the case and control group with regard to hs - crp level . previous studies showed a heightened state of oxidative stress following acute coronary syndrome and suggested that the pab value may be considered as a cardiovascular risk predictor to estimate the extent of oxidative stress . our study demonstrates that ginseng does not appear to have any significant effects on lipid profile , hs - crp level and pab . we suggest further clinical studies , with greater sample size , more prolonged period of therapy to investigate the therapeutic effects of ginseng . first , ginseng was administered at a dose of 500 mg / day for a limited period ( 8 weeks ) , and longer - term studies are necessary to show that this effect is sustained . second , using several doses of ginseng could have been useful to determine whether the observed effects of ginseng are dose - dependent and whether higher doses exert more dramatic effects .
background : because of the conflicting results from previous studies regarding the efficacy of ginseng on lipid profile and anti - inflammatory and anti - proliferative activities of its components , we aimed to evaluate the effects of panax ginseng on lipid profile , pro - oxidant  anti - oxidant status and high - sensitivity c reactive protein ( hs - crp ) levels.methods:forty iranian hyperlipidemic patients were randomly assigned to placebo ( n = 20 ) or control ( n = 20 ) groups in this double - blind randomized controlled trial . the ginseng or placebo was taken two capsules twice a day for 8 weeks . total cholesterol ( tc ) , triglyceride ( tg ) , low density lipoprotein cholesterol ( ldl - c ) , high density lipoprotein cholesterol ( hdl - c ) , fasting blood glucose , serum creatinine and hs - crp levels and pro - oxidant  anti - oxidant balance ( pab ) were estimated before and after intervention.results:there were no significant differences between the two groups with respect to changes in serum tg , ldl - c , hdl - c , and tc / hdl - c levels . 
 nor were there significant differences between the two groups with respect to changes in hs - crp level and pab from baseline to week 8.conclusions:our study demonstrates that ginseng does not have significant effects on lipid profile , hs - crp level and pab . 
 further clinical studies , with a larger sample size , more prolonged period of therapy are needed to investigate the therapeutic effects of ginseng .