Effect of Pancreas Tonic (an ayurvedic herbal supplement) in type 2 diabetes mellitus. Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. A randomized placebo controlled trial of Inolter (herbal product) in the treatment of type 2 diabetes. A preliminary evaluation of the efficacy and safety of Cogent db (an ayurvedic drug) in the glycemic control of patients with type 2-diabetes.
Although there is widespread use of herbal dietary supplements that are believed to benefit type 2 diabetes mellitus, few have been proven to do so in properly designed randomized trials; their efficacy for intermediate-term glucose control remains unclear. Pancreas Tonic is a botanical mixture of traditional Indian Ayurvedic herbs currently available as a dietary supplement. We report the results of a single-center, randomized, double-blind, placebo-controlled 3-month trial of Pancreas Tonic in type 2 diabetic patients inadequately treated with diet/lifestyle or stable doses of sulfonylureas and/or metformin for at least 3 months. Patients with type 2 diabetes for >/= 1 year were entered into 2 strata of hemoglobin A(1c) (HbA(1c)) levels (stratum 1: 8.0% to 9.9%; stratum 2: 10.0% to 12.0%). All subjects began a 1-month single-blind placebo run-in phase, followed by randomization in a 2:1 ratio of active treatment: placebo, to 3 months of double-blind treatment with either Pancreas Tonic or matching placebo (2 capsules 3 times a day). Concurrent oral agents were continued unchanged throughout the study. The primary outcome was the change in HbA(1c) from randomization; results of each stratum were analyzed independently. The baseline characteristics of 36 subjects who completed the study were comparable between treatment groups. Nineteen subjects entered stratum 1 and 17 entered stratum 2. A statistically significant reduction of HbA(1c) from randomization to end-of-study was seen in the stratum 2 subjects (Pancreas Tonic: 10.1% +/- 1.0% to 8.8% +/- 1.9%, P =.004; placebo: 10.8% +/- 1.4% to 11.2% +/- 1.8%, not significant [NS]). No significant HbA(1c) reductions were seen in the stratum 1 subjects. There were no significant treatment-related differences in the fasting plasma glucose (FPG), lipids, body mass index (BMI), body composition, blood pressure, insulin sensitivity estimates using the minimal model, glucose and insulin responses to a meal challenge, quality of life, adverse events, or other safety indices between treatment groups. Pancreas Tonic was well tolerated. Treatment with Pancreas Tonic (2 capsules 3 times per day) for 3 months significantly improved glucose control in type 2 diabetic patients with HbA(1c) levels between 10.0% to 12.0%. This study represents the first properly designed, prospective intervention trial of therapy with an Ayurvedic herbal supplement for intermediate-term glucose control in type 2 diabetes. 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.
                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.
                Patients were randomly assigned to either an experimental or control arm.
                Group model health maintenance organization. Participants: We recruited 60 adult patients with baseline glycosylated hemoglobin (HbA1c) values between 6.0 and 8.0.
                Treatment for the experimental group included exercise, an Ayurvedic diet, meditation instruction, and an Ayurvedic herb supplement (MA 471). Control patients attended standard diabetes education classes with primary care clinician follow-up.
                Clinical outcomes were assessed at 3 and 6 months and included HbA1c, fasting glucose, lipids, blood pressure, and weight.
                Ninety-two percent of randomized 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).
                These results suggest that the Ayurvedic intervention may benefit patients with higher baseline HbA1c values, warranting further research. To evaluate the safety and effectiveness of Inolter in achieving glycemic control and changes in lipid profile of newly diagnosed type 2 diabetics.
                Study design: A randomized, placebo-controlled double blind. Sixty newly diagnosed patients of type-2 diabetes were randomized. Of these, 30 were put on Inolter monotherapy and 30 patients on placebo. Efficacy of Inolter was determined by observing glycemic control by estimating glycosylated haemoglobin (HbA1c) and fasting blood sugar (FBS), alteration of lipid profile by serum cholesterol, LDL, VLDL, HDL and triglycerides.
                Student's unpaired 't' test.
                Patients compliance was satisfactory and no adverse effects were observed. Better hypoglycemic effect was observed with Inolter both respect to fasting blood sugar (mean 65.4 +/- 63.72 mg/dl) compared to placebo (mean 26.45 +/- 38.3 mg/dl) (p < 0.001). The mean change, with Inolter, in serum cholesterol (21.33 +/- 26.05 mg/dl), serum triglyceride (30.36 +/- 32.62 mg/dl), VLDL (8.85 +/- 3.25 mg/dl), LDL (10.00 +/- 4.48 mg/dl) and HDL (-2.33 +/- 5.66 mg/dl) was also significantly different (p < 0.001) from those given placebo, where it was 15.7 +/- 20.14 mg/dl, 8.70 +/- 13.24, 0.10 +/- 4.10 mg/dl, -0.70 +/- 4.58 mg/dl and 0.65 +/- 0.00 mg/dl, respectively.
                Inolter appears to be an useful adjunctive therapy to exercise and diet control in newly diagnosed type 2 diabetes mellitus. A nonrandomized, non-placebo-controlled clinical trial to evaluate the efficacy of Cogent db (an herbal preparation; Cybele Herbal Laboratories [PVT] Ltd. Kochi, Kerala State, India) as an adjuvant in the treatment of patients with type 2 diabetes was carried out during a 3-month period.
                This study was conducted in two major peripheral clinics of Kuala Lumpur in the Klang Valley, Malaysia.
                A total of 39 Cogent db-treated cases and 40 age-matched controls were recruited for this preliminary study. Nineteen (19) subjects (10 and 9 from control and treatment groups, respectively) dropped out of the study leaving a total of 60 subjects (30 each for control and treatment groups) who completed the study.
                All subjects in the treatment group were given Cogent db (2 tablets three times daily after each meal) in addition to the regular allopathic drugs (Daonil, [Aventis Farma, SA Petaling Jaya, Selangor State, Malaysia] and Diamicron [Sevier, Bangkok, Thailand], with or without Metformin [Upha Corporation, Bangi, Selangor State, India]) that they took in common with the control group.
                Thirty-two (32) clinical variables were investigated, including liver enzymes, kidney function tests, hematologic parameters, blood glucose, insulin, and C-peptide assays.
                At the end of 3 months it was found that there was a significant decrease in the levels of fasting and postprandial blood glucose, cholesterol, triglycerides, glycated hemoglobin (Hb A(1C)) and fasting insulin in the treatment group compared to the controls. Cogent db did not alter the liver function tests, hematologic parameters, or the kidney function tests.
                These results concur with earlier animal studies that indicate that Cogent db is safe, reliable, tolerable, and efficacious in the control of type 2 diabetes mellitus.