Effect of Nigella sativa seeds on the glycemic control of patients with type 2 diabetes mellitus. Protective role of Nigella sativa in diabetic nephropathy: A randomized clinical trial. Effect of Nigella sativa oil on various clinical and biochemical parameters of insulin resistance syndrome Effect of Nigella sativa supplementation over a one-year period on lipid levels, blood pressure and heart rate in type-2 diabetic patients receiving oral hypoglycemic agents: nonrandomized clinical trial Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Antihypertensive effect of Nigella sativa seed extract in patients with mild hypertension Randomized and double-blinded pilot clinical study of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus tea, as used in Nigerian traditional medicine. Effectiveness, safety, and tolerability of powdered Nigella sativa (kalonji) seed in capsules on serum lipid levels, blood sugar, blood pressure, and body weight in adults: results of a randomized, double-blind controlled trial. Herbal tea in the treatment of diabetes mellitus. A double blind randomised placebo controlled cross over study of a herbal preparation containing Salacia reticulata in the treatment of type 2 diabetes. Type 2 Diabetes: Demystifying the Global Epidemic A randomised controlled trial on hypolipidemic effects of Nigella Sativa seeds powder in menopausal women Chinese herbal medicine Tianqi reduces progression from impaired glucose tolerance to diabetes: a double-blind, randomized, placebo-controlled, multicenter trial. Clinical evaluation of Nigella sativa seeds for the treatment of hyperlipidemia: a randomized, placebo controlled clinical trial. The effectiveness of yoga to prevent diabetes mellitus type 2 Systematic medical assessment, referral and treatment for diabetes care in China using lay family health promoters: protocol for the SMARTDiabetes cluster randomised controlled trial Chinese herbal medicine for impaired glucose tolerance: a randomized placebo controlled trial
UNLABELLED Diabetes mellitus is a common chronic disease affecting millions of people world wide . St and ard treatment is failing to achieve required correction of blood glucose in many patients . Therefore , there is a need for investigating potential hypoglycemic drugs or herbs to improve glycemic control in diabetic patients .  Nigella sativa seeds were used as an adjuvant therapy in patients with diabetes mellitus type 2 added to their anti-diabetic medications . A total of 94 patient were recruited and divided r and omly into three dose groups . Capsules containing Nigella sativa were administered orally in a dose of 1 , 2 and 3 gm/day for three months . The effect of Nigella sativa on the glycemic control was assessed through measurement of fasting blood glucose ( FBG ) , blood glucose level 2 hours postpr and ially ( 2 hPG ) , and glycosylated hemoglobin ( HbA1c ) . Serum C-peptide and changes in body weight were also measured . Insulin resistance and beta-cell function were calculated usin the homeostatic model assessment ( HOMA2 ) . Nigella sativa at a dose of 2 gm/day caused significant reductions in FBG , 2hPG , and HbA1 without significant change in body weight . Fasting blood glucose was reduced by an average of 45 , 62 and 56 mg/dl at 4 , 8 and 12 weeks respectively . HbAlC was reduced by 1.52 % at the end of the 12 weeks of treatment ( P<0.0001 ) . Insulin resistance calculated by HOMA2 was reduced significantly ( P<0.01 ) , while B-cell function was increased ( P<0.02 ) at 12 weeks of treatment . The use of Nigella sativa in a dose of 1 gm/day also showed trends in improvement in all the measured parameters but it was not statistically significant from the baseline . However , no further increment in the beneficial response was observed with the 3 gm/day dose . The three doses of Nigella sativa used in the study did not adversely affect either renal functions or hepatic functions of the diabetic patients throughout the study period . IN CONCLUSION the results of this study indicate that a dose of 2 gm/ day of Nigella sativa might be a beneficial adjuvant to oral hypoglycemic agents in type 2 diabetic patients This study aims to evaluate efficacy and safety of Nigella sativa oil supplementation in patients with chronic kidney disease Stage 3 and 4 due to diabetic nephropathy . It was a prospect i ve , comparative , and open-label study . Patients were r and omized into two groups . Group 1 ( Control ) received conservative management of diabetic nephropathy , whereas Group 2 ( Test ) received N. sativa oil ( 2.5 mL , once daily and per orally ) along with conservative management for 12 weeks .  Blood glucose , hemogram , and kidney function test were done at 0 , 6 , and 12 weeks of treatment . Significance of differences between pre- and post-treatment values in each group was assessed using Student 's paired t-test and between the groups using unpaired t-test . We found a drop in blood glucose , serum creatinine , blood urea , and 24 h total urinary protein levels and a rise in glomerular filtration rate , 24 h total urinary volume , and hemoglobin level in the treatment group compared to the control group AIM : The seeds of the Nigella sativa plant have been used to promote health and fight disease for centuries , especially in the Middle East and in Southeast Asia . This plant has been a focus of much research . This clinical study was undertaken to know the adjuvant effect of N. sativa oil on various clinical and biochemical parameters of the insulin resistance syndrome . MATERIAL S AND METHODS : This prospect i ve study was conducted at a tertiary health care center in North India . After confirmation of diagnosis , 60 patients who fulfilled the inclusion and exclusion criteria were enrolled in this study . Written informed consent was taken from all the patients enrolled . Approval from the institutional ethical committee was also obtained . The patients were divided into two groups of 30 each . In group I ( the st and ard group ) , patients were advised tablet atorvastatin 10 mg once a day and tablet metformin 500 mg twice a day for a period of 6 weeks . In group II ( the N. sativa group ) , the patients were advised tablet atorvastatin 10 mg once a day , tablet metformin 500 mg twice a day , and N. sativa oil 2.5 ml twice daily for a period of 6 weeks . Fasting and postpr and ial blood glucose , fasting lipid profile , and waist circumference were recorded before therapy and after completion of therapy . RESULT : The treatment group showed significant ( P < 0.05 ) improvement with reference to total cholesterol , low density lipoprotein cholesterol ( LDL-C ) , and fasting blood glucose ( P < 0.05 ) . CONCLUSION : N. sativa oil was found to be effective as an add-on therapy in patients of insulin resistance syndrome . N. sativa oil has a significant activity in diabetic and dyslipidemic patients BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) .  DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group . The N sativa group had a significant decline in TC , LDL-C , TC/HDL-C and LDL-C/HDL-C ratios , compared with the respective baseline data and the control group . HDL-C was significantly elevated in the N sativa group . The control group showed a significant elevation in MAP . The N sativa group had a significant reduction in SBP , DBP , MAP and HR and a significant decrease in DBP , MAP and HR as compared with the control group . CONCLUSION N sativa supplementation improves total cholesterol , mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents .  LIMITATIONS There were 9 subjects in each group lost to follow up ; thus the sample size could not be maintained as per the sample size calculation . The study was nonr and omized and thus there was a possibility of allocation bias . ( Clinical trial registration number : CTRI/2013/06/003781 , Clinical Trial Registry of India ) CONTEXT Though complementary and alternative medicine ( CAM ) treatments are popular , evidence to support their application to diabetes care is scarce . Previous CAM diabetes research has generally focused on single modalities , but CAM practitioners more commonly prescribe complex , multimodality interventions . OBJECTIVES The aims of this study were to determine the feasibility and clinical impact of a whole-system , Ayurvedic intervention for newly diagnosed people with type 2 diabetes . DESIGN Patients were r and omly assigned to either an experimental or control arm . SETTING Group model health maintenance organization . PARTICIPANTS We recruited 60 adult patients with baseline glycosylated hemoglobin ( HbA1c ) values between 6.0 and 8.0 . INTERVENTION Treatment for the experimental group included exercise , an Ayurvedic diet , meditation instruction , and an Ayurvedic herb supplement ( MA 471 ) . Control patients attended st and ard diabetes education classes with primary care clinician follow-up . MEASUREMENTS Clinical outcomes were assessed at 3 and 6 months and included HbA1c , fasting glucose , lipids , blood pressure , and weight . RESULTS Ninety-two percent of r and omized patients completed the study , and there were no significant adverse study -related events . Using analysis of co-variance ( ANCOVA ) , we found no significant differences for clinical outcomes at 6 months between on- study patient groups , though trends favored the Ayurvedic group . When we included a factor measuring how much baseline HbA1c exceeded the mean ( 6.5 % ) , however , we found statistically significant improvements in the Ayurvedic group for HbA1c ( P = .006 ) , fasting glucose ( P = .001 ) , total cholesterol ( P = .05 ) , low-density lipoprotein ( LDL ) cholesterol ( P = .04 ) , and weight ( P = .035 ) . CONCLUSIONS These results suggest that the Ayurvedic intervention may benefit patients with higher baseline HbA1c values , warranting further research Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P < 0.05–0.01 ) . Meanwhile , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P < 0.01 ) when compared with the placebo group . In addition , extract administration reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT AIM OF THE STUDY The aim of this r and omized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus ( RC ) tea in humans . We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic ( BKS-db ) mice result ed in the normalization of blood sugar , reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas . The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk medicine . MATERIAL S AND METHODS The RC tea was produced using the Nigerian traditional recipe and tested in the traditional dosage on 23 Danish type 2 diabetes ( T2D ) patients . The participants were divided into two equivalent groups after stratification by sex , age and BMI , in a 4-month double-blinded , placebo-controlled and r and omized clinical trial . Most of the study subjects ( 19/23 ) were using oral anti-diabetic agents ( OADs ) . Mean disease duration was 6±4.6 years , mean age was 64±7 years and mean BMI was 28.7±3.8 kg/m(2 ) . Prior to starting the treatment , the participants received individual dietician consultations . RESULTS At the end of the 4-month treatment period , the treated group showed an 11 % decrease in 2-h postpr and ial plasma glucose relative to the 3 % increase in the placebo group ( p=0.004 ) . The improvement in blood glucose clearance with RC tea treatment was reflected in a 6 % reduction in HbA(1c ) ( p=0.02 ) and in a 10 % reduction in fasting plasma glucose ( p=0.02 ) , when comparing the post 4-month treatment to pre-treatment baseline values . Though the basal levels of phosphorylated acetyl CoA carboxylase enzyme in skeletal muscle were significantly reduced in the treated group ( p=0.04 ) , as compared to the placebo , only the pattern of reductions in the tissue fatty acids ( FAs ) differed in the two groups . While all types of FAs were reduced in placebo , only saturated ( SFA ) and monounsaturated ( MUFA ) FAs were reduced with treatment . Interestingly , a modest increase in the polyunsaturated FAs fraction was observed in the RC treated group . In addition , the reduction in SFA and MUFA with RC tea treatment came solely from the triglyceride fractions , as there was an increase in the skeletal muscle phospholipids . CONCLUSIONS Chronic administration of the RC tea to overweight T2D on OADs caused significant improvements in markers of glycaemic control and modifications to the fatty acid profile of skeletal muscle , without adverse effects or hypoglycaemia . Further exploration of the anti-diabetic effects of the RC tea is warranted OBJECTIVE The seed extracts from Nigella sativa is used by Unani physicians of traditional medicine ( Hakims or Tabibs ) and Ayurvedic practitioners ( Vaids ) in the treatment of several medical disorders including dyslipidemia , obesity , and hypertension . It is , therefore , important to prove or disprove the effectiveness , safety , and tolerability of powdered N. sativa ( Kalonji ) seed in capsules on serum lipid levels , blood sugar , blood pressure , and body weight in adults . DESIGN The study design was a r and omized , double-blind trial . SETTING S/LOCATION Conducted at Aga Khan University Hospital , Karachi , from February 2006 to January 2007 . SUBJECTS Half of the respondents received powdered N. sativa ( Kalonji ) seed in capsule and the rest received a placebo . INTERVENTION/ OUTCOME Baseline and after-intervention variables recorded were the following : body-mass index , waist-hip ratio , blood pressure , fasting blood sugar , serum lipids , serum alanine aminotransferase , and serum creatinine . RESULTS One hundred and twenty-three ( 123 ) patients were recruited . Sixty-four ( 64 ) and 59 patients were r and omized to the intervention and the control arms , respectively . Thirty-nine ( 39 ) patients in the intervention group and 34 in the control group completed the study . Favorable impact of powdered N. sativa ( Kalonji ) seed in capsule was noted on almost all variables , but results were not statistically significant because of small sample size . CONCLUSIONS Favorable impact of powdered N. sativa ( Kalonji ) seed in capsule was noted on almost all variables , but results were not statistically significant . A larger study with adequate sample size is recommended OBJECTIVE To evaluate the effects of a native herbal tea in patients with type 2 diabetes . DESIGN R and omized , placebo-controlled , single-blind study . SETTING The Metabolic Centre at the University of Alberta Hospitals . SUBJECTS Forty volunteers with type 2 diabetes . INTERVENTIONS After a 1 month " run-in " period , subjects drank 250 mL/d of either the herbal tea or a placebo tea for 10 days , and were followed up for a further 4 weeks . OUTCOME MEASURES A responder analysis defined as a 10 % change in mean blood glucose levels based on 4 capillary glucose readings daily . Secondary end points included changes in HbA1c , fructosamine and response to a meal challenge using Ensure . RESULTS The responder analysis showed no benefit from the herbal tea .  Fructosamine levels before and after tea therapy decreased significantly in both study groups . Mean HbA1c levels and incremental areas under the glucose curve ( AUC ) in the meal challenge did not change in either study group . These data were reanalysed in hyperglycemic subjects with HbA1c levels greater than 120 % of normal . The responder analysis and HbA1c levels did not change in either group . Mean ( and st and ard deviation ) fructosamine levels , before and after tea therapy , were significantly lower in the herbal tea group than in the placebo tea group ( 361 [ 98 ] versus 338 [ 100 ] micromol/L , p < 0.01 compared with 338 [ 60 ] versus 323 [ 49 ] micromol/L , p = 0.08 ) . In the hyperglycemic subgroup the mean AUC during the meal challenge , before versus after tea therapy , was 776 ( 369 ) versus 639 ( 331 ) mmol/L ( p = 0.22 ) in the herbal tea group and 433 ( 125 ) versus 420 ( 173 ) mmol/L ( p = 0.90 ) in the placebo group . CONCLUSIONS Although the responder analysis failed to show an effect of the herbal tea , the data suggest there may be a short-term benefit from the tea in subjects with poor glycemic control We conducted a r and omised single centre double blind cross over clinical trial to investigate the effects of a herbal tea containing Salacia reticulata ( Kothala Himbutu tea ) in patients with type II diabetes mellitus . Fifty-one patients with type II diabetes mellitus for longer than 6 months and with evidence of stable glycaemic control over the preceding 6 months ( as assessed by HbA1C ) participated in the study . They were r and omised to receive a st and ard preparation of Kothala Himbutu tea for 3 months followed by placebo in similar tea bags for a further 3 months ( n = 28 ) or in reverse order ( n = 23 ) . All patients received detailed advice on diet , exercise and lifestyle modification . HbA1C was measured at recruitment , at 3 months and on completion of the study at 6 months . Liver and renal functions were assessed biochemically at baseline , at 3 and 6 months and adverse events were recorded . There were no significant differences between the two groups in age , body mass index , male/female ratio , glycaemic control and baseline laboratory tests . All patients completed both arms of the trial . The HbA1C at the end of drug treatment was significantly lower than after treatment with placebo ( 6.29 + /- S.D. 1.02 versus 6.65 + /- S.D. 1.04 ; P = 0.008 ) . A statistically significant fall in HBA1c was seen with the active drug compared to a rise in HbA1C with the placebo group ( 0 . 54 + /- S.D. 0.93 ) versus -0.3 + /-S.D. 1.05 ; P < 0.001 . The daily mean dose of Glibenclamide fell by 1.89 ( S.D. 6.2 ) mg in the drug treated group but rose by 2.25 mg in the placebo treated group ( P = 0.07 ) . The differences in the metformin dose were not significantly significant in the two groups . We conclude that Kothala Himbutu tea is an effective and safe treatment for type 2 diabetes Type 2 diabetes ( T2D ) has attained the status of a global p and emic , spreading from affluent industrialized nations to the emerging economies of Asia , Latin America , and Africa . There is significant global variation in susceptibility to T2D , with Pacific Isl and ers , Asian Indians , and Native Americans being considerably more prone to develop the disorder . Although genetic factors may play a part , the rapidity with which diabetes prevalence has risen among these population s reflects the far-ranging and rapid socioeconomic changes to which they have been exposed over the past few decades . Traditionally , obesity and its correlate , insulin resistance , have been considered the major mediators of T2D risk ; however , recent evidence shows that early loss of β-cell function plays an important role in the pathogenesis of T2D , especially in nonobese individuals such as South Asians . Knowledge of the modifiable risk factors of T2D is important , as it forms the basis for design ing cost-effective preventive and therapeutic strategies to slow the epidemic in population s at increased risk . Lessons learned from r and omized prevention trials need to be implemented with appropriate cultural adaptations , accompanied by empowerment of the community , if the diabetes epidemic is to be slowed or halted Background The risk of cardiovascular diseases ( CVD ) is increased tremendously among menopausal women , and there is an increasing dem and for alternative therapies for managing factors like dyslipidemia that contribute to CVD development . Methods In this study , Nigella sativa was evaluated for its hypolipidemic effects among menopausal women . In a r and omised trial , hyperlipidemic menopausal women were assigned to  treatment ( n = 19 ) or placebo groups ( n = 18 ) , and given N. sativa or placebo for two months after their informed consents were sought . At baseline , blood sample s were taken and at one month intervals thereafter until one month after the end of the study . Results The results showed that N. sativa significantly improved lipid profiles of menopausal women  ( decreased total cholesterol , low density lipoprotein cholesterol and triglyceride , and increased high density lipoprotein cholesterol ) more than the placebo treatment over 2 months of intervention . One month after cessation of treatment , the lipid profiles in the N. sativa-treated group tended to change towards the pretreatment levels . Conclusions N. sativa is thought to have multiple mechanisms of action and is cost-effective . Therefore , it could be used by menopausal women to remedy hypercholesterolemia , with likely more benefits than with single pharmacological agents that may cause side effects . The use of N. sativa as an alternative therapy for hypercholesterolemia could have profound impact on the management of CVD among menopausal women especially in countries where it is readily available CONTEXT Living in a prediabetes state significantly increases a patient 's risk for both diabetes and cardiovascular disease .  Tianqi capsule , containing 10 Chinese herbal medicines , is used in China for the treatment of type 2 diabetes mellitus ( T2DM ) . OBJECTIVE The purpose of this study was to assess whether Tianqi prevented T2DM in subjects with impaired glucose tolerance ( IGT ) over the course of a 12-month treatment . METHODS Individuals with IGT were r and omly allocated in a double-blind manner to receive Tianqi ( n = 210 ) or a placebo ( n = 210 ) for 12 months . Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance . All subjects received the same lifestyle education . The primary endpoint was the conversion of IGT to T2DM . Body weight and body mass index were observed . Adverse effects were monitored . RESULTS Of the 420 enrolled subjects with IGT , 389 completed the trial ( 198 in the Tianqi group and 191 in the placebo group ) . At the end of the 12-month trial , 36 subjects in the Tianqi group ( 18.18 % ) and 56 in the placebo group ( 29.32 % ) had developed diabetes ( P = .01 ) . There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups ( n = 125 , 63.13 % , and n = 89 , 46.60 % , respectively ; P = .001 ) . Cox 's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by 32.1 % compared with the placebo . No severe adverse events occurred in the trial . There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the 12-month trial . CONCLUSIONS Treatment with a Tianqi capsule for 12 months significantly decreased the incidence of T2DM in subjects with IGT , and this herbal drug was safe to use BACKGROUND Natural products are proved to play a good role as an alternative to synthetic chemicals in many clinical conditions . Hypercholesterolemia is the most important risk factor for atherosclerosis . Previous studies showed that Nigella sativa L. has both antioxidant and lipid lowering potentials . THE AIM OF THIS STUDY To evaluate the efficacy of the seeds of Nigella sativa on the treatment of hyperlipidemia . METHODS In this r and omized , placebo controlled clinical trial which was conducted in Isfahan city ( Iran ) , 88 subjects aged > or = 18 years with a total cholesterol concentration > 200 mg/dl were included . According to the patients " profiles number , they were r and omized to receive either N. sativa capsules or the matching placebo . Each N sativa capsule contained 500 + /- 10 mg N. sativa crushed seeds , and patients had to take 2 g N. sativa per day for 4 weeks . Fasting baseline laboratory values ( fasting blood sugar , total cholesterol , low density lipoprotein , high density lipoprotein and triglyceride ) were obtained for all parameters on each subject prior to the start of the study and at the end of 4 weeks . RESULTS In our study a significant decrease was observed in the concentration of total cholesterol ( 4.78 % ) , Low density lipoprotein ( 7.6 % ) and Triglyceride ( 16.65 % ) , and this decrease was more significant for TG concentration .  N. sativa had not any beneficial effects on Fasting blood sugar and High density lipoprotein . CONCLUSION According to the results of our present study it seems that N. sativa may have some beneficial therapeutic effects in the treatment of hyperlipidemia . However , further investigations with a larger sample size are necessary Background : Type 2 diabetes mellitus ( T2DM ) is becoming a leading problem worldwide . Emerging reports reveal alarming evidence of increasing prevalence of T2DM that has reached p and emic levels . Despite the significant incidence , there are limited reliable data re sources and comprehensive systematic review and meta- analysis on the effects of yoga on people who are a prediabetic or high risk for developing T2DM . Objective : The objective of this protocol is to conduct a full-scale systematic review and meta-analyses on the effects of yoga on people who are prediabetes or high risk of developing T2DM . Methods : The articles enrolled in the study will be retrieved from the online data bases between 2002 and the date the search es are executed . The search es will be repeated just before the final analyses and further relevant studies for inclusion . We will conduct a bibliographic search in data bases : Medline / PubMed , Scopus , Cochrane Library , EBSCO , and IndMED using keywords including prediabetes state , high risk for diabetes , metabolic syndrome , and yoga . A defined search strategy will be implemented along with selection criteria to obtain full-text articles of relevant studies . This study protocol was prepared according to the Preferred Reporting Items for Systematic Review s and Meta- Analysis for Protocol s 2015 guidelines . There will be no language restrictions . Ethics and dissemination : The proposed study will be based on published studies and publicly available anonymized data without directly involving human participants and therefore requires neither formal human ethical review nor approval by a human research ethics committee . We published an outline of the protocol in the International Prospect i ve Register of Systematic Review s ( PROSPERO ) in 2018 . We plan to disseminate the findings of this systematic review and meta- analysis through publication in a peer- review ed journal and presentation at relevant conference proceedings . In addition , we believe the results of the systematic review will have implication s for policy and practice . We will prepare policymaker summary using a vali date d format , disseminate through social media and email discussion groups . Review registration number : PROSPERO registration number CRD Background Type 2 diabetes ( T2DM ) affects 113.9 million people in China , the largest number of any country in the world ( JAMA 310:948–59 , 2013 ) . T2DM prevalence has risen dramatically from around 1 % in the 1980s to now over 10 % and is expected to continue rising . Despite the growing disease burden , few people with T2DM are achieving adequate management targets to prevent complications . Health system infrastructure in China is struggling to meet these gaps in care , and innovative , cost-effective and affordable solutions are needed . One promising strategy that may be particularly relevant to the Chinese context is improving support for lay family members to care for their relatives with T2DM . Methods We hypothesise that an interactive mobile health management system can support lay family health promoters ( FHP ) and healthcare staff to improve clinical outcomes for family members with T2DM through medical assessment , regular monitoring , lifestyle advice and the prescribing of guidelines recommended medications . This intervention will be implemented as a cluster r and omised controlled trial involving 80 communities ( 40 communities in Beijing and 40 rural villages in Hebei province ) and 2000 people with T2DM . Outcome analyses will be conducted blinded to intervention allocation . The primary outcome is the proportion of patients achieving ≥2 “ ABC ” goals ( HbA1c < 7.0 % , blood pressure ( BP ) < 140/80 mmHg and LDL cholesterol < 100 mg/dl or 2.6 mmol/L ) at the end of follow-up ( Diabetes Care 36(Supplement 1):S11-S66 , 2013 ) . Secondary outcomes include the proportion of patients achieving individual ABC targets ; mean changes in HbA1c , BP , LDL , renal function ( serum creatinine and urinary albumin ) , body mass index , quality of life ( QOL , EQ-5D ) , and healthcare utilisation from baseline ; and cost-effectiveness/utility of intervention . Trial outcomes will be accompanied by detailed process and economic evaluations . Discussion The Chinese government has prioritised prevention and treatment of diabetes as 1 of 11 National Basic Public Health Services . Despite great promise for mHealth interventions to improve access to effective health care , there remains uncertainty about how this can be successfully achieved . The findings are likely to inform policy on a scalable strategy to overcome sub-optimal access to effective health care in China . Trial registration Clinical trials.gov Background Diabetes remains a major health problem worldwide . Low-risk low-cost alternatives to pharmaceutical interventions are needed where lifestyle modifications have failed . We conducted a double-blind r and omised placebo controlled trial to investigate the efficacy of a Chinese herbal formula , Jiangtang Xiaozhi , in treating impaired glucose control and insulin resistance in persons with prediabetes and controlled diabetes . Methods Seventy-one patients with prediabetes or ‘ controlled ’ diabetes were r and omised to receive 3 capsules of Jiangtang Xiaozhi ( n = 39 ) or placebo ( n = 32 ) three times daily for 16 weeks with a follow up eight weeks later ( week 24 ) . The primary outcome was change in glycaemic control as evidence d by fasting blood glucose ( FBG ) , post-pr and ial plasma glucose and glycosylated haemoglobin ( HbA1c ) . Other measures included change in fasting insulin , insulin resistance and sensitivity , lipids , C-reactive protein ( CRP ) , body mass index ( BMI ) , waist girth , blood pressure ( BP ) , health related quality of life ( HRQoL ) and safety . Analysis of covariance ( ANCOVA ) was used to model outcomes at 16 weeks , by treatment group corrected for baseline level of the outcome variable . Results In patients receiving Jiangtang Xiaozhi , FBG was not significantly different ( p = 0.73 ) compared to placebo after 16 weeks of treatment ( 6.3 ± 1.1 mmol/L vs 6.7 ± 1.3 mmol/L ) . There was a significant difference ( p = 0.04 ) in the mean levels of fasting insulin between the treatment group ( 11.6 ± 5.5 mmol/L ) and the placebo group ( 22.1 ± 25.9 mmol/L ) . Insulin resistance slightly decreased in the treatment group ( 1.58 ± 0.74 ) compared to that of the placebo group ( 2.43 ± 1.59 ) but this change did not reach statistical significance ( p = 0.06 ) . Patients taking Jiangtang Xiaozhi had a significant improvement in high-density lipoprotein ( HDL ) level compared to the placebo group at week 16 ( p = 0.03 ) . Mean levels of cholesterol , triglycerides , BMI , waist-girth , HRQoL , BP , CRP and insulin sensitivity were not significantly different between the two groups . The herbal medicine was well tolerated . Conclusions In the current study , the 16 week Jiangtang Xiaozhi treatment did not lower fasting blood glucose , but it improved serum  insulin and HDL cholesterol in a Western population with prediabetes or controlled diabetes . Our trial may have been underpowered . Dosage needs to be considered before commencing a longer adequately powered trial . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12612000128897;https://www.anzctr.org.au/Trial/ Registration /Trial Review
Although , the meta- analysis conducted included a few number of studies , but has shown promising results on the effectiveness of N. sativa on glucose homeostasis and serum lipids .
BACKGROUND & OBJECTIVE ( S ) Global prevalence of type 2 diabetes ( T2D ) is very high and is currently growing alarmingly .
With respect to recent research ers ' attention to the potential role of herbal medicine in disease prevention and management , the present meta- analysis review investigates the effectiveness of Nigella sativa ( N. sativa ) , a popular herb , in T2D .